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Doreen Lechner, program director, BioPharma Educational Initiative

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

Postbaccalaureate Certificates in Clinical Research

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 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 post-baccalaureate certificate, you will gain foundational knowledge towards becoming a clinical research professional with a thorough understanding of the increasingly complex drug and device development process. Graduates of the online certificate program have the opportunity to transfer all 15 credits to Rutgers SHP online Master of Science in Clinical Research Management program.

Our Post Baccalaureate Certificate has three specialized areas (15 credits)

  • Certificate in Clinical Trials Recruitment Sciences
    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.
  • Certificate in Clinical Trials Regulatory Affairs
    The laws and guidelines that regulate the clinical research, marketing approval, manufacture, and advertising of drugs, biologics, and medical devices are complex and ever-changingThe goal of the program is to prepare students to interpret regulations, conduct regulatory filings, and gain a thorough understanding of policies governing product development
  • Certificate in Drug Safety and Pharmacovigilance
    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. Student are prepared 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.

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 Programs 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.
  • 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 university ranked #1 in best colleges for health professions education by College Factual in 2018

Clinical Trials Regulatory Affairs

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

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:

· 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

Clinical Trials Recruitment Sciences

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.

Employment Opportunities:

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 Recruitment Sciences:

· 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 study 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 and Pharmacovigilance

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.

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 • 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 • Describe databases containing adverse drug events, such as MedDRA and Eudravigilance and explain how they are used

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.

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 “Practical Considerations 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