Master of Science Clinical Trial Sciences2018-09-04T19:53:59+00:00
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Doreen Lechner, program director, BioPharma Educational Initiative

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Program Director
Doreen W. Lechner, Ph.D.

M.S. and Postbaccalaureate Certificate in Clinical Trial Sciences

The online Biopharma Educational Initiative brings the pharmaceutical and biotechnology industries together with academics in a partnership to develop career-enhancing educational opportunities for existing or future biopharmaceutical employees. Through a master’s degree or a post-baccalaureate certificate, you will become a clinical research professional with a thorough understanding of the increasingly complex drug and device development process.

Our program prepares students to work in the biopharmaceutical industries, regulatory agencies, contract research organizations or academia with the primary objective of assisting with the execution and reporting of clinical drug and device trials. Students will become familiar with clinical trial fundamentals, comprehensive understanding of the regulatory and legal framework guiding the planning, execution, completion and reporting of clinical trials and to be able to perform specific duties based on the student’s area of specialization.

Our distance-learning program offers a:

Master of Science in Clinical Trial Sciences in four specialized tracks (36 credits)

  • Regulatory Affairs
  • Clinical Trial Management and Recruitment
  • Drug Safety and Pharmacovigilance
  • Medical Affairs

Post Baccalaureate Certificate in one of three specialized areas (15 credits)

  • Certificate in Clinical Trials Recruitment Sciences
  • Certificate in Clinical Trials Regulatory Affairs
  • Certificate in Drug Safety and Pharmacovigilance

We recommend that you contact the Program Director, prior to applying to our program so we can answer any questions you may have.

Doreen W Lechner, PhD
Rutgers Biopharma Educational Initiative
SSB, Suite 359
Rutgers School of Health Professions
65 Bergen Street
Newark, New Jersey 07107
P:  973-972- 6482 || biopharma@shp.rutgers.edu

  • Our online program is part of Rutgers Biomedical and Health Sciences, one of the largest health care research institutions in the U.S., with its own Contract Research Organization and well-regarded research facilities.
  • Our online courses are designed for the busy working professional with enrollment options for full-time and part-time students.
  • Opportunities for networking with industry leaders and gifted principal investigators are valuable assets offered to our students.
  •  Our program is supported by an Advisory Committee composed of clinical research professional internal and external stakeholders.
  • Our proximity to pharmaceutical and biotech companies enables recruitment of  faculty who are subject matter experts in clinical research. In addition, our adjunct faculty are employed in the pharmaceutical industry.
  • A mentored fieldwork capstone experience through a prospectively planned and approved healthcare related/pharmaceutical research, educational, clinical, administrative, or community service project.
  • Through an initiative between Rutgers and the DIA association, students can earn Continuing Education credits while completing an academic program.

Specialized tracks:

The laws and guidelines that regulate the clinical research, marketing approval, manufacture, and advertising of drugs, biologics, and medical devices are complex and ever-changing. Regulatory Affairs professionals interpret and utilize these regulations throughout a drug/device lifecycle in order to bring a product to the market. Regulatory Affairs professionals write technical documents, review advertising and labeling, and are involved with regulations governing the manufacturing of products. The goal of the program is to prepare students to interpret regulations, conduct regulatory filings, and gain a thorough understanding of policies governing product development

Professional Association
Regulatory Affairs Professionals Society: (RAPS) www.raps.org

Employment Opportunities:

Regulatory Affairs professionals are involved in every stage of the drug/device lifecycle, applying a regulatory framework to product development. They prepare regulatory submissions to the authorities, review product claims, and assess compliance with regulations. They may also be involved in post-market surveillance and the development of risk-minimization plans. Regulatory Affairs individuals may also monitor compliance in the manufacturing arena.

Competencies for Regulatory Affairs Track:

  • Develop and submit applications for permission to study and market products to a variety of international and national regulatory agencies
  •  Interpret regulations involved in the investigation, production, labeling and distribution of drugs, food, additives, medical devices, biological products, pesticides and other similar products, and provide guidance on these rules to the project team
  •  Assist in protocol development to satisfy new requirements for post-marketing commitment studies
  • Understand the various regulatory documents involved in pharmacovigilance
  •  Develop Regulatory Strategies that enable the launch of drugs in foreign markets
  • Identifying concepts involved with GXP as it relates to Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs); Outline the steps in a preventive action investigation by documenting the background of the issue and to identify a corrective action to the deviation and a suggested timeline of completion

This track teaches the knowledge and skills necessary to become a Clinical Research Associate/Monitor (CRA) or a Clinical Research Coordinator (CRC) who is able to manage the growing number of clinical drug trials both in the US and abroad. Students will learn to develop strategies for patient recruitment and retention, and test out the validity of these methods scientifically, with the goal of safely speeding up the drug approval process. The overall goal for the Clinical Trial Management & Recruitment Track is for students to acquire the knowledge and skills necessary for effective clinical trial management from both sponsors and study site perspectives.

Professional Associations

Association for Clinical Research Professionals (ACRP): www.acrpnet.org
Drug Information Association (DIA): www.diahome.org
Society for Clinical Research Association (SOCRA): www.socra.org 

Employment Opportunities: 

With the number of registered clinical trials skyrocketing according to ClinicalTrials.gov, along with an uptick in new reporting mechanisms and policies, there is a booming industry with a workforce that may not be able to keep up with demand in the coming years. Possible jobs include:

Clinical Research Associate (CRA) are individuals designated by sponsors (pharma company) to monitor the progress of a clinical investigation. They are employees of a pharma company or work for a CRO (Contract Research Organization). CRAs can also be independent contractors.  Most have a bachelor’s or master’s degree in natural or medical sciences.  CRA tasks include editing protocols for studies, writing informed consents, assuring that principles of Good Clinical Practice are adhered too, selecting investigational sites, and conducting study initiation, monitoring visits and closeout.

Clinical Research Coordinator (CRC) are professionals designated by the principal investigator to lead a study at the site level. They are involved with study start-up, subject recruitment, screening patients, and enrollment, as well as implementation and data management. They may also negotiate the study budget with the CRA and submit to the IRB. CRCs may also create study documents like subject tracking logs, medication tracking logs, and organize study binder and source documents. The CRC is responsible for collecting data and making sure the study is conducted as outlined by the sponsor.

Competencies for the Clinical Trial Management Track:

  •  Demonstrate knowledge of pathophysiology and pharmacology
  • Interpret the appropriate portion of the CFR and use this document to guide the
    execution of Clinical Research professional
  • Conduct study specific activities for a study and conduct protocol feasibility such
    as preparing case report forms/electronic data capture, storage of studny materials
    and documents, informed consent documents, as well as budget, close-out
    procedures and perform post study analysis
  • Design and monitor recruitment campaigns with an understanding of influences
    such as disease, pharmacogenomics, culture and religion
  • Research and test methodologies used for patient recruitment to develop evidence
    based approaches to this study area
  • Formulate a business plan for a clinical trial including managing external funding,
    budgeting processes, cost-benefit and cost-effectiveness data
  • Demonstrate a working knowledge of databases used to capture outcomes,
    biomarkers, and endpoints from the site investigators
  •  Design a quality assurance plan to coincide with study initiation procedure

Drug Safety specialists are needed to develop tools to identify adverse drug reactions at an earlier stage in development, recognize signals that suggest adverse drug reactions, and effectively create risk-minimization tools. Every drug, biologic, and medical device has a risk-to-benefit ratio. Some risks are known early in the development phase and can be predicted by preclinical studies. However, many safety issues first come to light only after large-scale clinical trials are conducted in the post-marketing phase of development. As drug recalls grow, there has been a greater emphasis on identifying signals both in the clinical phase of study and after the product has been released on the market. The overall goal is to prepare the students to assist in recognizing, quantifying, analyzing, and communicating adverse events to the proper regulatory authorities, and to develop mitigation strategies to prevent future adverse events.

Professional Associations:

Pharmaceutical Information and Pharmacovigilance Association (PIPA): www.pipaonline.org
International Society of Pharmacoepidemiology (ISPE): www.pharmacoepi.org/
International Society of Pharmacovigilance: www.isoponline.org

Employment Opportunities

Drug Safety Officer/Pharmacovigilance Specialists monitor the safety of drugs, biologics, and medical devices. They review reports of adverse events from patients, regulatory agencies, healthcare professionals, and investigational sites, and then write safety reports for the Healthcare Authorities. They are also involved in data mining to screen for adverse events (signal detection) and assess the risk and benefits of medical products, as well as develop risk management plans. A clinical background is preferred as well as a thorough understanding of the regulatory requirements both in the US and abroad. However, there are individuals who may fill positions in drug safety departments who are involved with data collection, report writing and quality management and do not necessarily require past clinical experience.

Competencies for the Drug Safety & Pharmacovigilance Track

• Analyze differences in safety regulations/guidances between different global
regions
• Analyze adverse events based on seriousness and labeledness/ expectedness
• Prepare drug safety narrative
• Describe the key drug safety reporting requirements that must be filed with a
regulatory agency
• Outline traditional and statistical data mining methods
• Perform risk identification (signal detection) and characterize identified risks,
potential risks based on signal analysis to develop a risk management plan
• Identify the different Risk Management Tools such as RMPS and REMS
• Review published literature of clinical and preclinical reports to provide a
framework to judge adverse events
• Describe databases containing adverse drug events, such as MedDRA and
Eudravigilance and explain how they are used
• Identify major drug induced adverse events or safety signals and the rationale for
their development

This specialization track teaches the knowledge and skills necessary to enter various facets of medical affairs. Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market while performing activities overlapping with sales, medical marketing, clinical growth, and customer service. In parallel, Medical Affairs also serves as the bridge between the company’s internal stakeholders, especially clinical development and the company’s external stakeholders. Medical Affairs’ focus on generating meaningful evidence, strategic engagement of key opinion leaders and the dissemination of relevant scientific information making it paramount for them to ensure their knowledge and skills are well supported by a formidable education system.  The overall goal is to educate students on the role of medical affairs in commercialization, in particular, to develop research hypotheses and designs for medical affairs studies, disseminate study results in an effective and efficient way to various stakeholders, design communication strategies, develop brand strategies, understand stakeholder needs (e.g., regulatory affairs, market access) and develop strategies for win-win partnerships, address challenges that medical affairs faces in commercialization, and interpret regulatory and clinical guidelines.

Professional Associations: 

Medical Affairs Professional Society (MAPS): www.medicalaffairs.org
Drug Information Association (DIA): www.diahome.org

Employment Opportunities

Employment in the medical affairs area offers opportunities to become medical sciences Liaisons, medical information professionals, medical advisors and medical directors. These positions are necessary to manage the growing vital sector in today’s bio pharmaceutical industry in providing key opinion leaders, regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products.

Medical Science Liaisons (MSL) are individuals designated by sponsor (pharma company) to be  physician facing and are able to discuss both the disease and the product apart from what marketing does.  They are employees of a pharma company or work for a CRO (Contract Research Organization).  MSLs can also be independent contractors.  Most have a PharmD, PhD in natural or medical sciences, MPH or MD.  MSL activities include delivering presentations, KOL management and education, advisory committee support.

Medical information professionals are focused on publications, tracking the use of the biopharmaceutical products and its advertising, verifying its viability, compliance, developing plans for publications, and other types of communications.

Medical advisors and medical directors are individuals typically holding a medical degree and are in charge of the medical affairs team and ancillary service. They must be scientifically sound and able to develop studies, manage them, tack them and produce viable data which can be published or presented in conferences, cultivate relationships with KOLs and HCPs, run programs such as patient supported programs, named patient or compassionate use programs and oversee the support provided by their company to investigator initiated trials.

Competencies for the Medical Affairs Track

• Scientific and technological thought leadership to enable to think
across therapeutic areas, assess critical value, analyze risk versus benefit and
exploit technological advances
• Demonstrate a deep understanding of compliance in order to appreciate the
options and constraints of an increasingly compliance driven environment
• Develop emotional intelligence and communication skills to understand and
engage customers and colleagues
• Formulate and Implement strategies to partner with commercial and development
colleagues and engage in lifecycle planning; understand the changing customer
landscape
• Demonstrate business leadership to partner with commercial and development
colleagues and engage in lifecycle planning; understand the changing customer
landscape
• Apply and demonstrate learning agility to take current knowledge and adapt it for
future use both within and outside the core medical capability

Upon completion of the program students will be able to:

• Formulate a basic study design incorporating knowledge on sample size, placebo
response, significance, blinding, minimizing bias, randomization, as well as
concepts surrounding multiple analyses and multiple treatment arms and
endpoints;
• Select and utilize appropriate software for data entry, tracking recruitment, and
managing the budget and expenditures for study managers;
• Improve research designs and epidemiological studies, and identify how changes
in health policy and economics influence study design;
• Critique the drug literature with regard to study design, methods, statistics, quality
of literature review, conclusions, and writing style and organization;
• Apply ethical principles to the development and conduct of clinical trials, including
informed consent and subject recruitment and retention, and identify cases of
error, misconduct and fraud;
• Interpret and summarize major regulatory documents in the U.S. and compare and
contrast these with international regulations;
• Assess adverse effects by utilizing several methods including severity scales,
toxicity criteria, and similar response variables, and document the event for the
sponsor, appropriate regulatory agencies, and in the literature;
• Explain the drug/device/biologic evaluation process including all phases of product
development in clinical research and GCP guidelines impact on quality
• Disseminate study results in the form of reports to regulatory agencies, to the
sponsor and contributions to publications in medical journals;
• Construct plans for training investigators and/or study staff to promote
standardization of study procedures;
• Discuss principles of pharmaceutical project management and identify
components of the project strategy (target product profile, business strategy,
clinical strategy, regulatory strategy, financial analysis);
• Identify important clinical questions to develop a research hypothesis;
• Learn how to provide safe, competent clinical care to the participants in clinical
trials.

Our program is developed on a competency-based framework of the following domains;

  • Scientific Concepts and Research Design
  • Ethical and Participant Safety Considerations
  • Medicines Development and Regulation
  • Clinical Trial Operations
  • Study and Site Management
  • Data Management and Informatics
  • Leadership and Professionalism
  • Communication and Teamwork

Biopharma External Advisory Group

Bonnie A. Brescia (BBK Worldwide)

Ms Brescia is one of the two founding principals of BBK Worldwide, Bonnie led the company’s evolution as a first-of its-kind marketing consultancy specializing in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology, and medical device industries. A well-recognized thought leader in patient recruitment, Bonnie firmly established BBK as a pioneer in developing marketing and technology solutions that ease bottlenecks in the clinical development process. With over 30 years of marketing communications and financial management experience, Bonnie manages and develops BBK’s worldwide alliance of companies, ensuring a multinational foundation for initiatives like BBK’s global investigator network and Web-based recruitment portal.

Barton Cobert, MD, FACP, FACG, FFPH

Dr. Cobert has had a long career in the clinical practice of Gastroenterology and Internal Medicine as well as in the pharmaceutical industry specializing in clinical research, drug safety and compliance/risk management. For over a decade he was Global Head of Drug Safety (side effects) for the ScheringPlough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert received his MD from New York University School of Medicine where he also trained in medicine and gastroenterology. He did a post-doc in hepatology in Pars, France. He is board certified in Internal Medicine and Gastroenterology. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigiliance which is used as a textbook in courses on drug safety. Dr. Cobert is now president of BLCMD Associates LLC, a drug safety pharmacovigilance consultancy.

David H. Hom, MS (Boston University)

Mr. Hom has over 20 years experience in the development, conduct and management of IND phase IIII clinical trials. His initial work including working onsite in Uganda, in the early 1990’s as part of a research team established by Case Western Reserve University and Makerere University conducting early research into HIV/AIDS pathogenesis and associated opportunistic infections. Later trials included a large phase III trial of preventive therapy for TB in high-risk PPD+ subjects sponsored by the US CDC; a variety of phase II trials of various immunoadjuvants for TB sponsored by NIH/NIAID; a phase I/II trial of a NNRTI (nevirapine) for preventing mother-to-child HIV transmission sponsored by Boehringer Ingelheim Pharmaceuticals, Inc and Africa’s first HIV preventative trial (AlVAC-vCP250) sponsored by Pasteur-Merieux Connaught and NIH-NIAID. He also directed the Clinical and Data Coordinating Center for the NIH’s Tuberculosis Research and Prevention Unit (TBRU) based at CWRU. He has over 50 peer-reviewed publications and 100 peer-reviewed abstracts presented at national and international conferences.

Kenneth A. Getz, MBA (Tufts Center For The Study Of Drug Development)

Kenneth Getz is a Senior Research Fellow at the Tufts Center for the Study of Drug Development where he focuses on studying R&D management, study volunteer trends, and policies affecting the Biopharmaceutical industry. Ken is also the chairman of the Center for Information & Study of Clinical Research Participation and founder and owner of CenterWatch. In addition he has an extensive presentation list and has published more than 200 articles and book chapters. He is an active member of the DIA and is serving as the chair of their Annual meeting in Chicago in 2011. Ken holds an AMBA from the J.L. Kellogg Graduate School of Management at Northwestern University.

Laura Perry, MBA, MSW, LSW ( Extraordinary Parent Coaching)

Laura Perry is the founder and an education advocate of Extraordinary Parent Coaching where she focuses on adoptive families and those with special needs including mental health issues. She is a dedicated social services professional with experience and training that includes PTSD, developmental trauma and interpersonal violence as well as program coordination, family advocacy and social work case management. Laura is a former executive in the biopharmaceutical industry with extensive staff management and operations experience across the sector. Laura holds an advisory board position on the San Fernando Valley Counseling Center as well as volunteers as an education advocate at CASA for Children of Essex County.

Carlotta M. Rodriguez, BS, CIP (RBHS)

Carlotta M. Rodriguez, BS, CIP, is the director of the University of Medicine and Dentistry of New Jersey Newark Campus IRB, where she is responsible for managing four IRB committees. As a member of the Institutional Animal Care and Usage Committee, Institutional Biosafety Committee, and the Radiation Safety Committee, she serves as a liaison between these committees, university administration, and researchers and educators amongst the nine distinct schools that form the university. She is currently overseeing the implementation of a campus-wide eIRB submission and reviewer process. She is a member of PRIM&R (Public Responsibility in Medicine and Research), ACRP (Association of Clinical Research Professionals) and SRA (Society of Research Administrators). Prior to assuming her role as IRB director, she worked within the Human Subjects Protection Office to develop the current department-focused approach employed university-wide.

Nancy C. Santanello, M.D., M.S. (Merck Research Laboratories)

Dr. Santanello is a physician-epidemiologist trained in Emergency Medicine and Preventive Medicine with a Masters of Science degree in Epidemiology. She is board certified by the American College of Preventive Medicine in Preventive Medicine and Epidemiology. Prior to joining Merck, Dr. Santanello was a Medical Officer with the National Heart, Lung, and Blood Institute (NHLBI) Prevention and Demonstration Research Branch of the Division of Epidemiology and Clinical Applications (1987-1991). From 1991 to present, Dr. Santanello has been in the Department of Epidemiology at Merck Research Laboratories; in 2003 she was appointed to the position of head of that department. Her areas of research interest include: the development and validation of outcome measures for use in clinical trials, study design, adherence to therapy, satisfaction with and preference for therapy, effectiveness studies, and drug and vaccine safety/pharmacoepidemiology. In 1998 Dr. Santanello received the Merck Directors Award, the Company’s highest honor, from the Board of Directors for her work in support of clinical and outcomes research measures for asthma. Dr. Santanello has published over 60 peer-reviewed manuscripts. Dr. Santanello is the President-Elect of the International Society for Pharmacoepidemiology (ISPE).

Meredith Y. Smith, MPA, PhD. (Abbott Laboratories)

Dr. Smith is Senior Scientific Director of Risk Management in Global Pharmaceutical Research and Development at Abbott Laboratories. Dr. Smith has a background in both public health and health services research and has held positions in local, state and federal agencies including the U.S. Centers for Disease Control. She has more than 10 years experience in the pharmaceutical industry in the area of health outcomes research and risk management. In her current position she develops, implements and evaluates global risk minimization strategies for an array of pharmaceutical products, including opioid analgesics, biologics and drug-device combination products. Previously, she served as Director of Risk Management at Purdue Pharma, LLP. Prior to joining the pharmaceutical industry, Dr. Smith held faculty positions at Memorial Sloan-Kettering Cancer Center and the Mount Sinai School of Medicine in New York City. Dr. Smith has received research grants from the National Institutes of Health, the Agency for Health Care Research and Quality, the American Cancer Society and the Susan B. Komen Cancer Foundation and has published over 40 peer-reviewed articles. She currently serves as a member of the CIOMS Working Group IX “PracticalConsiderations for Development and Application of a Toolkit for Medicinal Product Risk Management.”

Erika Stevens, MA (Ernst & Young)

Erika Stevens is a Senior Manager in the Advisory Services practice of Ernst & Young. She has over 15 years of clinical research experience, including over 12 years in clinical research management serving in roles such as the Director of Clinical Trials Office, Regulatory Training Manager, Interim Executive Director of Clinical Trials Office and Director of Research Operations Prior to joining Ernst and Young, Erika served as the Director of Clinical Trials Office at Dartmouth Hitchcock Medical Center, where she lead the promotion, development, management/operations and strategic plan for clinical trial research including the financial, regulatory, training, operations and compliance services to Dartmouth College and Dartmouth-Hitchcock facilities. She also served as the Interim Executive Director of the Clinical Trials Office at Columbia University Medical Center, Director of Research Operations at Washington University School of Medicine and worked in project management at the University of Pennsylvania School of Medicine.

Admissions requirements for each program are listed below.

Apply here by Nov. 15 for Spring 2019 admission and by June 30 for Fall 2019 admission.

  1.  Bachelor’s degree or higher with a minimum GPA of 3.0. If applying to the Drug Safety Track, a clinical background in medicine, nursing, pharmacy, or allied health, is suggested but not required .
  2. Complete application form online.
  3. Two letters of recommendation from individuals who can assess your professional ability and potential for successful graduate studies. Enter email address of individual you are requesting the recommendation from in the online application to request recommendations from either a professional or academic source.
  4. A 250-word statement about your short-term and long-term career goals. Attach as a supporting document to your online application.
  5. $70.00 application fee (non-refundable)
  6. Official transcript from highest degree attained. Mail directly to: Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  7. Resume indicating employment and educational background should be attached as supporting document to your online application.
  8.  Credential Evaluation: Applicants who have attended an educational institution in a foreign country are required to have their transcript(s) evaluated by a transcript evaluation service. WES is preferred but please visit http://www.naces.org/members.htm for other acceptable agencies. Official reports are to be mailed directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101.
  9. A passing TOEFL test score (min. of 79 Internet based) is required for individuals who have a foreign degree from countries where English is not an official language. Official electronic TOEFL reports should be sent from vendor directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  10. The Graduate Records Examination (GRE) is not required.

For students moving from the Certificate or Non-Matriculated programs to the Masters Curriculum, credits for all track courses and approved electives with a grade of B or better will be accepted.

For individuals who may be applying close to the established deadlines, the option of choosing to enroll in individual courses as non-matriculates or visiting students is also available. Such students should follow the requirements listed for the Certificate Programs noted in the certificate section below in consultation with the Biopharma Office (biopharma@shp.rutgers.edu).

Apply by Nov.30 for a Spring 2019 start and by July 15 for a Fall 2019 start.

  1.  Bachelor’s degree or higher with a minimum GPA of 3.0. If applying to the Drug Safety Track, a clinical background in medicine, nursing, pharmacy, or allied health, is suggested but not required.
  2. Complete application form online.
  3. One letter of recommendation from an individual who can assess your professional ability and potential for successful graduate studies.
  4. A statement about your short-term and long-term career goals included on the application.
  5. $100.00 application fee (non-refundable)
  6. Official transcript from highest degree attained. Mail directly to: Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  7. Resume indicating employment and educational background should be attached as supporting document to your online application.
  8.  Credential Evaluation: Applicants who have attended an educational institution in a foreign country are required to have their transcript(s) evaluated by a transcript evaluation service. WES is preferred but please visit http://www.naces.org/members.htm for other acceptable agencies. Official reports are to be mailed directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101.
  9. A passing TOEFL test score (min. of 79 Internet based) is required for individuals who have a foreign degree from countries where English is not an official language. Official electronic TOEFL reports should be sent from vendor directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  10. The Graduate Records Examination (GRE) is not required.

For students moving from the Certificate or Non-Matriculated programs to the Masters Curriculum, credits for all track courses and approved electives with a grade of B or better will be accepted.

Certificate Students and Non-Matriculated students are not eligible for financial aid. There are private loan options available in coordination with the financial aid office. Please request information from the financial aid office if you are interested in pursuing this option.

Apply by Nov. 30 for Spring 2019 admission and by July 15 for Fall 2019 admission.

Please follow the guidelines below.

  1. Bachelor’s degree or higher with a minimum GPA of 3.0. If applying to the Drug Safety Track, a clinical background in medicine, nursing, pharmacy, or allied health, is suggested but not required
  2. Complete application form online https://apps.shp.rutgers.edu/projects/CACEcert/cert_main.cfm
  3.  A statement about your short-term and long-term career goals included on the application.
  4. $100.00 application fee (non-refundable)
  5. Official transcript from highest degree attained. Mail directly to: Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  6. Resume indicating employment and educational background should be attached as supporting document to your online application.
  7.  Credential Evaluation: Applicants who have attended an educational institution in a foreign country are required to have their transcript(s) evaluated by a transcript evaluation service. WES is preferred but please visit http://www.naces.org/members.htm for other acceptable agencies. Official reports are to be mailed directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101.
  8. A passing TOEFL test score (min. of 79 Internet based) is required for individuals who have a foreign degree from countries where English is not an official language. Official electronic TOEFL reports should be sent from vendor directly to Rutgers School of Health Professions Office of Enrollment Services, 65 Bergen Street, Room 149, Newark, NJ 07101
  9. The Graduate Records Examination (GRE) is not required.

For students moving from the Certificate or Non-Matriculated programs to the Masters Curriculum, credits for all track courses and approved electives with a grade of B or better will be accepted.

For individuals who may be applying close to the established deadlines, the option of choosing to enroll in individual courses as non-matriculates or visiting students is also available. Such students should follow the requirements listed for the Certificate Programs noted above in consultation with the Biopharma Office (biopharma@shp.rutgers.edu).

Students from Rutgers Biomedical and Health Science legacy credit-driven schools may enroll in Biopharma Initiative courses upon obtaining written authorization from their academic advisor. Students would then seek registration through the enrollment services staff of their school who will collaborate with Biopharma staff in facilitating the process.  Registration is on a space-available basis and is accomplished using the Cross-Registration form.

We recommend that you contact the program director so we can answer any questions you may have:

Doreen W Lechner, PhD
Program Director, Rutgers Biopharma Educational Initiative
P:  973-972- 6482
biopharma@shp.rutgers.edu

The M.S. in Clinical Trial Sciences is a 36-credit program consisting of a 9-credit core, along with 27 credits of specialization courses and electives. The core curriculum provides foundational information in research design, ethics, drug discovery, and federal and international regulations governing drug and device development. The program culminates in a capstone project in which students can perform a project at their job, participate in a mentored fieldwork experience, or write a systematic review for publication under the guidance of faculty.

Our post-baccalaureate certificate in Clinical Trials Recruitment Sciences, Clinical Trials Regulatory Affairs or Drug Safety and Pharmacovigilance is a 15-credit program consisting of a 9-credit core, along with 6 credits of elective courses and electives. The core curriculum provides foundational information in research design, ethics, drug discovery, and federal and international regulations governing drug and device development.

Course information including course description, goals, objectives, pre-requisites and textbook information can be found at the link below. By clicking on the course number, you can also access to the course information.

https://apps.shp.rutgers.edu/projects/CourseCatalog/RGs/CTS5.pdf

For a list of required courses, please click here.

For course information including course description, goals, objectives, pre-requisites and textbook information, please click the Course Catalog. By clicking on the course number, you can also access to the course information. This page does not list required courses for certificate students, but is a reference for all other course information. 

Our faculty and staff are always available to speak with you about any questions you may have about the Biopharma Educational Initiative. If you need to reach us you may contact us as noted: 

Barbara Gladson, PhD
Director and Professor, Biopharma Educational Initiative
Interim Chair, Health Informatics
(973) 972-2375
gladsobh@shp.rutgers.edu 

Doreen W. Lechner, PhD
Program Director and Assistant Professor, MS Clinical Trial Sciences
(973) 972-5984
lechnedw@shp.rutgers.edu

Iris Pena
Program Assistant, Biopharma Educational Initiative
(973) 972-8444
Iris.pena@rutgers.edu

Biopharma Educational Office
Stanley S Bergen Building
Suite 359
Newark, New Jersey   07107
Phone (973)972- 6482 | Fax (973)972-7228
biopharma@shp.rutgers.edu 

Student-Faculty Advisors

Doreen W. Lechner, PhD
Program Director and Assistant Professor, MS Clinical Trial Sciences
(973) 972-6482
lechnedw@shp.rutgers.edu

Nadina Jose, MD
Assistant Professor, MS Clinical Trial Sciences
(213)928-5093
ncj26@shp.rutgers.edu

Lisa Palladino Kim, MS
Lecturer and Capstone Director, MS Clinical Trial Sciences
(484)686-0896 or +82-010-7621-7079
palladlm@shp.rutgers.edu

Patricia Beers Block, M.Distance Ed Lecturer,
MS Clinical Trial Sciences
(410) 446-8844
beersbpm@rutgers.edu

Hetu Gadhia, PhD Lecturer,
MS Clinical Trial Sciences
(732) 476-4242
hgadhia@shp.rutgers.edu

For newly admitted students to the MS Clinical Trial Sciences Program, congratulations and we are excited to welcome you. We have provided a summary of next steps below

  1. Once enrollment services receives your deposit and signed Applicant Response Sheet you will receive an onboarding letter with your Student ID # (“A” number) which includes instructions on how to activate your computer accounts using the ‘NetID’ Activation secure site. This letter will also include a registration PIN #. NOTE: There is a 72 hr wait period before you can register from when your deposit was received.
  2. Once you have established your University credentials, the next step is to register for classes using your registration PIN# and your NetID by logging onto Access Banner Self-Service through myportal.rutgers, the Web Portal into the Rutgers community. Registration is located under “Banner Self-Service” Student Enrollment Services.  You can also use Banner to update and view personal information, class schedule, and the course catalog.
  3. Our program will send a welcome letter outlining a few details regarding the program along with a request to set up an appointment with your advisor prior to registering for your courses.
  4. If you register after on-line registration closes youcomplete an ADD/DROP form  and return it to enrollment services. Since this is your first semester at SHP you will not be charged a late fee.  However in subsequent semesters, if you register late you will be charged a $50.00 fee.
  5. Once you have set up your NetID and password you will be able to log into Rutgers Moodle, https://moodle.rutgers.edu.    This will give you access to the Our e-Learning system.  The login will bring you to your Moodle Homepage.  You should then see your courses listed.
  6. While you are waiting for classes to begin, please familiarize yourself with our Biopharma Policies and Procedures and log into Moodle site and take the Student Tutorials.
  7. As an online student you will have access to our wonderful Virtual Library for Distance Learning which includes full-text journals, full-text books and numerous databases utilized by the student enrolled in a health care curriculum.
  8.  Immunizations:  As part of your enrollment packet you will receive a form asking for a listing of immunizations.  A doctor’s signature is not needed for completion, just fill in the form yourself as best you can.  You will not need any additional immunizations however you must fax this form in to enrollment services.
  9. Future Registration:  You will need a brand new PIN number prior to each registration period.  At the time that MS Priority Registration Begins, students will receive their web registration PIN via their Rutgers e-mail account.

For newly admitted students to the Post-Baccalaureate Certificate or as a Non-Matriculated Student, Congratulations and we are excited to welcome you. We have provided a summary of next steps below

  1. Once accepted you will receive a letter containing your on-boarding information with your Student ID # (“A” number) including instructions on how to activate your computer accounts using the ‘NetID’ Activation secure site. An activated NetID will give you access to our e-learning program (moodle) and “My University Portal” containing personal information, class schedule and the course catalog.
  2. Your first step is to register for courses by completing the Biopharma registration form:Online Registration.  Then you will be able to set up your “NetID”.  You will receive further instructions once your registration form is submitted.
  3. Our program will send a welcome letter outlining a few details regarding the program along with a request to set up an appointment with your advisor prior to registering for your courses.
  4. If you register after on-line registration closes you complete anADD/DROP form and return it to enrollment services. Since this is your first semester at SHP you will not be charged a late fee.  However in subsequent semesters, if you register late you will be charged a $50.00 fee.
  5. Once you have set up your NetID and password you will be able to log into Rutgers Moodle, https://moodle.rutgers.edu.    This will give you access to our e-Learning system.  The login will bring you to your Moodle Homepage.  You should then see your courses listed.
  6. While you are waiting for classes to begin, please familiarize yourself with our Biopharma Policies and Procedures and log into Moodle  http://moodle.rutgers.edu site and take the Student Tutorials.
  7. As an online student you will have access to our wonderful Virtual Library for Distance Learning which includes full-text journals, full-text books and numerous databases utilized by the student enrolled in a health care curriculum.

 Course registration for Master’s degree is through access Banner Self-Service through myportal.rutgers, the Web Portal  into the Rutgers community. Registration is located under “Banner Self-Service” Student Enrollment Services.

Course registration for Post-baccalaureate certificate and Non-Matriculated students is through the Biopharma registration form: Online Registration.

Students must attend a Capstone Overview session and submit Appendix A Capstone Proposal Form (must be filled out by all students)at least one semester before the student is expected to enroll in their Graduate Capstone, Evidenced Based Literature course or Scientific Writing for the Translation of Medicine Course. Please send proposal form or any questions to lisa.palladino.kim@rutgers.edu.

Capstone Project Course Syllabus

For Mentors of Capstone Students

For students performing a field mentorship, contracts need to be finalized by:

  • For Fall semester  – end of July
  • For Spring semester – end of November
  • For Summer semester – end of April

The Biopharma Educational Initiative follows policies outlined by the School of Health Professions, as well as the policies listed below. To view our schoolwide policies, please see the

Student Handbook

Biopharma Policy Manual

Change of Student Program Status

Minimum Grade Point Average

Time for Program Completion

Transfer Credit

It is an online learning program designed as a collaboration between industry and academia to develop career enhancing educational opportunities for existing or future biopharmaceutical employees. The program offers four areas of specialization:  clinical trial management and recruitment; regulatory affairs; drug safety and pharmacovigilance; and medical affairs. 

The certificate program is a 15-credit program vs. the 36 credit Master’s degree; it provides individuals an option to introduce themselves to foundational courses in an area of specialty in the clinical research space.  Certificate students are not eligible for financial aid. 

This program educates individuals to become Clinical Research Professionals who possess a thorough understanding of drug and device development. 

  • Bachelor’s degree or higher with a minimum GPA of 3.0
  • Two letters of recommendation.
  • Application including a 250-word statement acknowledging your short-term and long-term career goals
  • Official transcript from highest degree attained
  • Resume indicating employment and educational background
  • Credential evaluation if attended a  university outside the US
  • TOEFL exam for individuals who have a foreign degree from countries where English is not the official language
  • Bachelor’s degree or higher with a minimum GPA of 3.0
  • One letter of recommendation.
  • Application including a brief goal statement
  • Official transcript from highest degree attained
  • Resume indicating employment and educational background
  • Credential evaluation if attended a  university outside the US
  • TOEFL exam for individuals who have a foreign degree from countries where English is not the official language
  • Bachelor’s degree or higher with a minimum GPA of 3.0
  • Application including a brief goal statement
  • Official transcript from highest degree attained
  • Resume indicating employment and educational background
  • Credential evaluation if attended a  university outside the US
  • TOEFL exam for individuals who have a foreign degree from countries where English is not the official language

You may apply online through the MS application https://admissionservices.rutgers.edu/graduate/newApplicant.app   .

Apply online for the post-baccalaureate certificate or as a non-matriculated student (ADD LINK)

for the Rutgers School of Health Professions. We recommend you contact the Program Director prior to starting the application process at 973-972- 6482.

Yes. You should follow the requirements listed for the non-matriculated Students in consultation with the Biopharma Office. A non–matriculated student may not take more than 12 credits in the program.

Our tuition is credit based on the master’s degree, post-baccalaureate certificate or non-matriculated student. Our rate is $1009/ credit. Please note that all fees are included in the tuition; for MS, there is an initial general service administrative fee of $50.  Tuition and charges are subject to change at any time at the discretion of the University 

Yes, it is available for Master’s Degree student. Contact the Rutgers Student Financial Aid Office at 973-972-4376 or click here.  

Yes, scholarships are available for Master’s Degree Students. Contact the Rutgers Student Financial Aid Office or call 973-972-4376 or Rutgers SHP scholarships can be found here.

Our program offers courses over three terms: Fall, Spring and Summer term. However, it is not mandatory to take courses over the Summer term.

They are online courses that allow you to participate in a learning environment from your home, office or any site that has a computer with the appropriate browser and internet access.  These courses differ from traditional online courses correspondence courses in that they require ongoing participation and interaction with the instructor and other students in the class.

This active participation is achieved in many different ways depending on the course.  In general these courses require readings from a textbook, journal articles, or visits to websites.  Online discussions (Discussion Forums) with the instructor and students assist in the interpretation, synthesis, and analysis of the readings, while the written assignments are generally structured to assist in applying the information to one’s practice.  Our courses include video clips, lecture handouts, and video-streaming.  Emphasis is placed on developing a conceptual framework supported by the evidence in the literature.

In general, participation in our web based  courses entails approximately 10-12 hours of course work per week.  This includes time spent logging onto the content on a daily basis during the work week, participation in discussions, written assignments and assigned readings.  Time spent writing papers and/or studying and taking exams are included in this estimate.

The mode of instruction in web-based courses is directed study, an active learning method that emphasizes what the learner does, as opposed to traditional classroom learning that stresses what information the professor teaches to the students.

In web-based courses, you learn and apply the content by completing structured assignments and activities. The instructor’s role is to (1) design the assignments and activities to ensure active learning, (2) provide guidance and feedback to help the student successfully complete the assignments, and (3) promote collaboration among the students by participating in discussions. The success of these courses very much depends on the quality and frequency of the students’ contributions.

Dept. Home
APPLY NOW for M.S.
APPLY NOW for CERT. & NON-MATRIC.
Doreen Lechner, program director, BioPharma Educational Initiative

To learn more, email
Program Director
Doreen W. Lechner, Ph.D.