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Doreen Lechner, program director, BioPharma Educational Initiative

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Program Director
Doreen W. Lechner, Ph.D.

M.S. Clinical Research Management

A  clinical research professional’s work has the potential to deliver cutting edge-technology and treatment that contributes to the future of health care delivery and improved outcomes for patients. The clinical research industry relies on professionals who are specially trained to navigate the complex world of medical product development to ensure safe and effective treatments to reach patients.

The Master of Science in Clinical Research Management is a 36-credit multi-disciplinary curriculum offered online by the Rutgers School of Health Professions .  It builds a broad and well-rounded foundation for the clinical research professional. Two paths can be selected:

1) Clinical Research Management The core program covers the theory and practice of research methods, statistics, regulatory and legal framework of clinical investigations, clinical research operations, project management, leadership skills, disease process, and regulatory writing. Through the core courses, the competencies outlined by the Clinical Research Professional Core Competency Framework will be met. Students take additional courses defining their area of specialization in patient engagement, advertising and labeling, medical devices, international regulatory affairs, medical affairs, or clinical data management.

2) Clinical Research Management –Drug Safety and Pharmacovigilance The core program focuses on drug safety basics and regulations, risk management, signal detection, pharmacoepidemiology, theory and practice of research methods, regulatory requirements of clinical investigations, disease process and pharmacology.

Both programs culminate with a capstone project, which is an experiential training opportunity to apply best practices learned in the classroom at a clinical research site or at a bio-pharma company.

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
Clinical Research Management Program
SSB, Suite 359
Rutgers School of Health Professions
65 Bergen Street
Newark, New Jersey 07107
P:  973-972- 6482 ||

  • 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.
  • Alumni are eligible for a Clinical Research Management Fellowship funded through NJACTS, a NIH CTSA hub.
  • Online courses are designed for the busy working professional with enrollment options for full-time and part-time students.
  • Completion of  MS degree is a substitute for CRA or CRC work experience towards your CCRA or CCRC eligibility requirements.
  • Opportunities for networking with industry leaders and gifted principal investigators are valuable assets offered to our students.
  • Courses are composed of blended activities carefully designed to deliver challenging and engaging content taught by Rutgers faculty with subject matter expertise in clinical research from pharmaceutical companies, CRO and government agencies
  •  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.
  •  A university ranked #1 in best colleges for health professions education by College Factual in 2018

There is a robust job market for clinical research professionals with the increase in the amount of research that is being conducted and limited resources available. According to the Bureau of Labor Statistics employment in the  clinical research profession is projected to grow 13% over the next ten years.

With the number of registered clinical trials skyrocketing according to, along with an uptick in new reporting mechanisms and policies, there is a booming industry with careers in the following types of jobs:

Clinical Research Associate /Clinical Research Coordinator/ Clinical Research Monitor – Typically represents the sponsoring company or the Clinical Research Organization (CRO). Oversees the conduct of the study at the trial sites, ensuring that the data are collected and submitted according to how the protocol is designed, and monitor the study for patient safety issues.

Patient Recruitment Specialist –  A relatively new role in the industry which grew out of the need to develop cost-effective strategies for patient recruitment and retention which are involved in testing the validity of strategies to speed up the drug approval process. These individuals also develop the tools and processes for effective recruitment activities and implement them along with the CRAs/CRCs at investigative sites globally. They may work for the sponsor, CRO, or for independent companies that specialize solely in global recruitment.

Medical Science Liaisons (MSL) – Individuals designated by sponsor (pharma company) to be  physician-facing and able to discuss both the disease and the product, apart from marketing.  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 Advisors –   Individuals typically holding a medical degree who are in charge of the medical affairs team and ancillary service. They must be scientifically sound and able to develop studies, manage them, track 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.

Drug Safety Officer/Pharmacovigilance Specialist – Drug safety personnel monitor the safety of drugs, biologics and medical devices. They review reports of adverse events from patients and HCPs as well as clinical investigational site– they prepare safety reports to submit to Regulatory Health Authorities and mine the data to screen for adverse events and look for signals of new events as well as assess the risk and benefits of medical products, as well as develop risk management plans.

Typically a clinical background is preferred, along with a thorough understanding of the regulatory requirements. However, individuals who fill positions in drug safety who are involved with data collection, report writing and quality management do not necessarily require past clinical experience.

Medical Monitor –  The safety officer within the sponsoring company or CRO who tracks and manages any safety issues or adverse events.

Clinical Research Regulatory Compliance Professional – Ensures compliance to regulations and all other regulatory activities involved with filing information with the regulatory bodies. They submit and manage the documents required by the regulatory health authority to test new drugs or devices. If they work at investigator sites, they may work at the Institutional Review Board or with the Principal Investigator preparing documents to filing with the regulatory health authority for investigator-initiated studies.

Our goal is to prepare competent entry level and advanced level Clinical Research Professionals in the cognitive, psychomotor and affective learning domains through 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

Upon completion of the MS Clinical Research Management program students will be able to:

· Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization, safety management as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints;

· Apply an understanding of the history of ethical and cultural issues, informed consent, inclusion and exclusion criteria in regard to human subject protection and privacy as well as safety as it relates to the drug development process

· Summarize the specific processes in line with regulatory and legislative framework that ensures safety, efficacy and quality for regulatory authority approval for the marketing authorization for a medical product

· Understand the framework of global clinical operations as it relates to Good Clinical Practice, study conduct and management; safety profile management and control and handling of investigational product.

· Identify and explain the specific procedural, financial, documentation, and oversight requirements of PIs, sponsors, site personnel, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial

· Describe how data sets the stage as a critical role in a clinical trial including electronic data capture, the importance of information technology in data collection, capture, management, correction and queries.

· Identify and implement the practice of leadership and project management of the ethical and professional conflicts that are associated with the conduct of clinical research and project strategy

· Discuss the various elements of communication between the site and sponsor, health authorities and contract research organizations as well as within the site through the understanding of multidisciplinary teamwork skills necessary for conducting a clinical trial.

Upon completion of the MS Clinical Research Management-Drug Safety and Pharmacovigilance program students will be able to:

· Design a clinical and translational study incorporating, sample size, placebo response, statistical significance, blinding, minimizing bias, randomization safety management, as well as concepts surrounding multiple analyses and multiple treatment arms and endpoints;

· Summarize the principles of pharmacoepidemiology, pharmacogenomics and other drug safety science to analyze potential safety issues and understand the patient population and the risks in the drug development process

· Summarize the specific drug safety function and processes in line with regulatory and legislative framework that ensures safety and quality though the various phases that must be followed in order for the regulatory authority to approve the marketing authorization for a medical product

· Understand the framework of drug safety and pharmacovigilance operations as it relates to US and EMA rules, regulations and initiatives governing both safety reporting (ICSR and aggregate reports) and processing data from clinical trials and post-marketing environments including CIOMS and ICH guidelines.

· Explain the development and maintenance of Pharmacovigilance System Master File, Safety Management Plans and Safety Data Exchange Agreements across clinical study programs and post marketing activities.

· Identify the data sources, data capture, data assessment(seriousness; labeledness/ expectedness and causality), data management practices, database tools and MedDRA dictionary for narrative preparation and analysis of clinical and post-marketing safety data

· 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

· Identify and implement the practice of leadership and project management through the role of key drug safety professionals with the drug safety function associated with the conduct of clinical research, product strategy and responding to regulatory authority inquiries.

· Discuss the various elements of communication for a cohesive quality management system including effectively preparing and conducting audits and inspections across the site and sponsor, health authorities and contract research organizations as well as within the site through the understanding of multidisciplinary teamwork skills necessary for collecting and querying safety data in a clinical trial

Rutgers is accredited by the Middle States Commission on Higher Education (MSCHE), a voluntary, nongovernmental, peer-based membership association dedicated to promoting standards of excellence and improvement in higher education.

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.

Craig H. Lipset, MPH

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is a growth advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants. He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research, the MedStar Health Research Institute, and the People-Centered Research Foundation (the central office for PCORnet), as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig has been listed among the PharmaVOICE most inspiring people in the life sciences, Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who’s Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia. When not working to accelerate research, Craig can be found at hockey rinks, dance recitals, or dog walks.

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.

MS Clinical Research Management or MS Clinical Research Management-Drug Safety and Pharmacovigilance

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

1. Bachelor’s degree or higher with a minimum GPA of 3.0. No previous clinical research professional experience is required for entry. 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 and select either Clinical Research Management or Clinical Research Management- Drug Safety and Pharmacovigilance

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 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 Rutgers SHP Biopharma Certificate or Non-Matriculated programs to the Masters Curriculum, credits for these certificate 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 is also available. Such students should follow the requirements listed for the certificate programs noted in the certificate section.

Our curriculum aligns with the Joint Task Force Core Competencies for Clinical Research Professionals and is carefully designed to ensure that all of its students will graduate with the core competencies and more than sufficient specialist knowledge to pursue career opportunities in the Pharmaceuticals/CROs, Academia or Government and related sectors. By offering a solidified core, students will benefit from a focused, targeted and relevant body of knowledge upon which the student can depend on to support their journey towards achieving career advancement. Additionally, the elective courses will allow students to select courses of interest after taking the core courses to explore areas which will build on the introductory and reinforcing concepts covered in the core courses and will lead to a mastery of specific concepts: patient engagement, advertising and labeling, medical devices, international regulatory affairs, medical affairs, or clinical data management.

The M.S. in Clinical Research Management  is a 36-credit program consisting of a 30-credit core, along with 6 credits of specialization course  electives. The core covers  theory and practice of research methods, statistics,  regulatory  and legal framework of clinical investigations,  clinical research operations,  project management, leadership skills, disease process, and regulatory writing and 6 credits of specialized electives.

The M.S. Clinical Research Management –Drug Safety and Pharmacovigilance is a 36 – credit program consisting of a 33- credit core which focuses on  drug safety basics and regulations, risk management, signal detection, pharmacoepidemiology, theory and practice of research methods, regulatory requirements of clinical investigations,  disease process and pharmacology and 1 credit of specialized elective.

Both programs culminate in a capstone project in which students earn 3 credits which  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.