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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.

  • 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.
  •  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 ClinicalTrials.gov, 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

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.

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.

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.

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),