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

Interpret laws, regulations, guidelines and ethical aspects applicable to the conduct of clinical investigations supporting new drug approvals including human subject protections; sponsor and clinical Investigator activities; and Institutional Review Board oversight.

• • • Assist in protocol development as it relates to clinical trial fundamentals, research design, drug development phases.
    • Demonstrate the basics of conducting a trial and its overall impact on a product’s journey from concept to commercialization.
    • Understand the various regulatory documents involved in pharmacovigilance.
    • Develop regulatory strategies that enable the launch of drugs in foreign markets

Clinical Trials Recruitment Sciences

This track teaches the knowledge and skills necessary to become a Clinical Research Professional 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.

Employment Opportunities:

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 sponsor and submit to the IRB.. 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.
    • 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.
    • Interpret laws, regulations, guidelines and ethical aspects applicable to the conduct of clinical investigations supporting new drug approvals including human subject protections; sponsor and clinical Investigator activities; and Institutional Review Board oversight.
    • Assist in protocol development as it relates to clinical trial fundamentals, research design, drug development phases.

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
    • 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

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 35 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.

Elena Dubcenco, MD  

Dr. Dubcenco is a Medical Director in Drug Development at AbbVie Inc. Prior to joining AbbVie Inc., Dr. Dubcenco was a Medical Director at Ferring Pharmaceuticals Inc. and prior to moving to Ferring, she was an Associate Medical Director at Robarts Clinical Trials Inc./Western University.

Dr. Dubcenco holds a MD degree, and completed training in Internal Medicine. She then went on to complete her clinical research Fellowship in Inflammatory Bowel Disease and Advanced Endoscopy at University of Toronto in Canada, and Research Fellowship in Natural Orifice Transluminal Endoscopic Surgery at John’s Hopkins University in the United States. Dr. Dubcenco earned her M.S.  degree in Clinical Trial Sciences from Rutgers, the State University of New Jersey along with the Oak Ridge Institute for Science and Education (ORISE) Fellowship at the United States Food and Drug Administration (FDA).

In 2008 Dr. Dubcenco received Cook Medical Don Wilson Award from the American Society for Gastrointestinal Endoscopy followed by the Outstanding Clinical Reviewer Award from the Gastrointestinal Endoscopy (GIE) Journal in 2009. In 2011 Dr. Dubcenco received the NOSCAR Olympus Medical Systems Research Award and Grant from the American Society for Gastrointestinal Endoscopy and Society of American Gastrointestinal and Endoscopic Surgeons. She has published numerous peer-reviewed articles.

David H. Hom, MS

Mr. Hom has over 30 years’ experience in the development, conduct and management of IND phase I-III clinical trials of therapeutics and devices in infectious diseases-primarily HIV/AIDS and Pulmonary Tuberculosis. 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 has/is also directed several  Clinical, Operations and Data Coordinating Center for the NIH programs at Case Western, Boston University and Rutgers University, with collaborating institutions in Uganda, Kenya, South Africa, Brazil, India, Korea and China. He has over 60 peer-reviewed publications and 100 peer-reviewed abstracts presented at national and international conferences.

Kathleen Nagle, MS, CCRP

Kathleen Nagle, is currently a Clinical Project Manager at Kiniksa Pharmaceuticals.  Prior to assuming this role, she has worked for the past six years at both Clinical Research Organizations (CROs) and academic medical centers in varying clinical research capacities. She earned her Masters of Science in Clinical Trial Sciences degree, with a focus on Clinical Trials Management and Recruitment, from Rutgers School of Health Professions in 2018.

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

Laura Perry is a licensed social worker with focus on women and children. She currently serves as an adult and youth counselor with Safe + Sound Somerset, the lead domestic violence agency in Somerset County NJ.  She is also part of the domestic violence response team partnering with local law enforcement to provide psychological support and safety planning for women who are survivors of domestic violence. Previously she worked with women in recovery from opioid addiction and their children under a NJ state grant to help address the ongoing opioid addiction crisis in the state.  Prior to moving into the private non-profit sector, Laura was  an executive in the biopharmaceutical industry with 25 years of staff management and operations experience across the sector from drug development through post-marketing surveillance activities.

Carlotta M. Rodriguez, BS, CIP

Carlotta M. Rodriguez, MS, CIP, CHRC is the Director of Rutgers the State University of New Jersey, Health Sciences Campus  where she is responsible for managing four Institutional Review Board (IRB) committees, the single IRB and Central IRB processes across all campuses.  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 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.

Dr. Santanello is a physician-epidemiologist, board certified in Preventive Medicine with a Masters of Science degree in Epidemiology. 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 conducting clinical trials, epidemiology studies and developing physician training and patient education materials. Dr. Santanello previously held the Vice President and Head of the Epidemiology Department at Merck & Co. She is a Past-President of the International Society for Pharmacoepidemiology (ISPE) and a Fellow of ISPE. Dr. Santanello is the current Chair of the PhRMA Foundation Health Outcomes Advisory Committee and an advisor to PhRMA on outcomes research, real world data, and assessing value. Her areas of research interest include: drug and vaccine safety/pharmacoepidemiology, clinical outcome assessments, effectiveness studies, the development and validation of patient reported outcome (PRO) measures for use in clinical trials, trial and observational study design, use of external controls, adherence to therapy. Currently Dr. Santanello is co-leading an ISPE working group of researchers from FDA, EMA, pharmaceutical companies and academia in an effort to incorporate real-world data in clinical trial programs.

Meredith Y. Smith, MPA, PhD.

Dr. Meredith Smith is a behavioral scientist and health services research by training  with over 15 years of experience in the pharmaceutical industry.  In her current role as Director of Risk Management at Alexion Inc., she oversees a state-of-the-art risk management monitoring system, and is building capacity for digital risk minimization measures, structured benefit-risk assessment and patient-centered approaches to risk management. In terms of professional service, Dr. Smith has been an invited participant in risk management workshops and panels sponsored by the US Food and Drug Administration, and has also served as a co-author and co-editor of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products.  Dr. Smith is currently a member and Case Study Co-Lead of IMI-PREFER, an international working group seeking to develop consensus recommendations on methods for patient preference elicitation for benefit-risk assessment, and a Group Lead in CIOMS XI, Patient Involvement in the Development and Safe Use of Medicines. She has published widely in the peer-reviewed literature.

Erika Stevens, MA

Erika Stevens leads research transformation advisory and assurance services. In this capacity, she advised cancer centers, life sciences, AMCs, hospitals and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing and compliance. Her regulatory knowledge and quality oversight of the Code of Federal Regulations (CFR) includes, but is not limited to, GMP, GLP and GCP. Ms. Stevens has over 20 years of research/ R&D experience, including over 12 years in research management serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations.  Ms. Stevens is a past president of the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Ms. Stevens served as chair, for two terms, of the editorial advisory board for “The Clinical Researcher,” the peer reviewed journal publication for Association of Clinical Research Professionals (ACRP). Ms. Stevens is the treasurer of the Associate Board of Trustees. Erika serves on the MAGI advisory board and is a director for Brightpoint Health. She is also a frequent speaker on research operations and compliance practices at international conferences. Additionally, she is a published author whose work appears in a variety of peer journals including the American Journal of Obstetrics & Gynecology, The Monitor, Clinical Researcher, Regulatory Focus, Applied Clinical Trials, Clinical and Translation Science and the Journal of Mental Health and Aging. Ms. Stevens holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University. She also holds a Graduate Certificate in Gerontology from Case Western University.

• • 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 Master’s 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.

• • 1. Bachelor’s degree or higher with a minimum GPA of 3.0.
    2. Complete application form online.
    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 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 below in consultation with the Biopharma Office (biopharma@shp.rutgers.edu).

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.

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 recruitment; regulatory affairs; and drug safety and pharmacovigilance.

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 exposes individuals to the foundational knowledge to become Clinical Research Professionals who will possess a thorough understanding of drug and device development.

• • • 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 for the post-baccalaureate certificate or as a non-matriculated student. 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. Tuition and charges are subject to change at any time at the discretion of the University.

Unfortunately, it is not available for Certificate or non-matriculated students.

Our program offers courses over three terms: Fall, Spring and 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 or 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 12-15 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.