The field of clinical research is focused on developing cost-effective ways to treat disease and increase quality of life through successful development and launch of new biologics, devices, and pharmaceuticals and by incorporating the science of genomics or personalized genetic prescribing.
Opportunities in the field are many and varied, ranging from the principal role of investigator to the supportive tasks surrounding regulatory compliance, scientific writing, marketing, data management and more. Employment settings include pharmaceutical, biotechnology, medical device companies, contract research, hospitals, educational institutions and independent contractors.
The Clinical Trials Management Online Certificate is offered 100% online and provides a broad overview of key competencies necessary for a successful understanding and conduct of the new product development process in today’s environment. Course topics include:
Clinical trials process, roles and responsibilities
U.S. regulatory compliance
Ethical and safety considerations
Data management and coding principles
Monitoring and oversight of clinical trials
New product introduction, branding and marketing
About the clinical research and product development field
New product development requires a broad collaboration among science and technology professionals who keep current in the medical and regulatory arena. The potential opportunities in the field of clinical trials management range from the principal role of investigator to the supportive tasks surrounding regulatory compliance, scientific writing, marketing, and retrieval of accurate and reliable data for submission to regulatory agencies.
The research team collaborates across several business units, starting with the sponsor of the investigative new product, to the clinical site that collects ongoing data from subjects receiving the product, to the sponsor or designee who monitors the quality of the data being collected. Professionals conducting clinical trials primarily come from healthcare backgrounds.
Clinical Trials Management Certificate LOCATION: ONLINE—This is a self-paced online course with some scheduled requirements. SCHEDULE: February 17- May 18, 2020 (online) PRICE: $2,125, all materials included. Potential discounts available: Early registration, Military, UD student or alum, 2 or more (group). CEUs: 2.0 (20 contact hours)
Michele Welch, RN, MSN, has over 20 years of experience in global pharmaceutical drug development at several large pharmaceutical companies, including AstraZeneca, Actelion and Abbvie. Her roles have included director of a field-based regional monitoring program and senior director of clinical study management, where she was responsible for management of in-house staff and accountable for the delivery of clinical trials across multiple therapeutic areas. In addition, Michele has held positions as project leader for a new drug application (NDA) submitted drug compound, and trainer in clinical development at Wyeth/Pfizer Pharmaceuticals. Prior to her career in the pharmaceutical industry, she practiced as an RN in various clinical agencies and taught nursing in academia. She received her BSN from the University of Delaware and her MSN from the University of Pennsylvania.
To earn the Clinical Trials Management Certificate, all three of the following modules must be successfully completed with a passing grade (60 or higher) and earn an overall final grade for the certificate of 70 or above.
1. Development: Setting Up the Environment for Success
This module provides an overview of the clinical and pre-clinical processes involved in setting up clinical trials, and the roles and responsibilities of those conducting and administering these processes. Topics include:
Ensuring that a proposed investigative site is qualified and appropriate for use in a clinical trial
Recruitment and retention of eligible study patients/participants
Compliance with U.S. regulatory bodies and ethical considerations: safety, efficacy, privacy
Comparison of human clinical testing models with animal testing models
Setting up for collection and delivery of unbiased, concise, and comprehensive scientific data
Code of conduct governing sponsors, sites, investigative personnel, and other affiliated parties
Case studies of ethical and safety violations in clinical trials, and their effect on new product development
2. Implementation: Carrying Through the Plan
This module focuses on the processes involved in conducting safe, thorough, and reliable clinical trials. Topics include:
Monitoring visits—purpose and importance of monitoring visits from the site and sponsor perspectives; roles and responsibilities of both site and sponsor in a successful outcome; essential points of a comprehensive site visit from both a regulatory and data management perspective; and what makes a highly proficient monitor
Obtaining valid and reliable data—components of an appropriate database, validation of associated systems, coding principles, and the sequence of events leading to a database lock
Emerging markets—how they contribute to the challenges of new product development, unique country/region mandates, effect of newly emerging markets in relation to the future of scientific experimentation
Reporting of safety concerns—how to appropriately report them to regulatory agencies, regulatory timelines for reporting, case studies
3. Integration: Creating the Package
This module focuses on the steps necessary for completion and evaluation of clinical trials processes. Topics include:
Ensuring that an investigative site has met all contractual and regulatory obligations
Follow-up checklist: disposition of outstanding product supplies, report data, etc.
Evaluation by the sponsor or agency regarding site and sponsor performance
Audits surrounding an NDA (New Drug Application) filing, random and for-cause
Introducing a product to health-care practitioners and consumers: market research, advertising principles, governmental rules and regulations, product branding
Effectively reporting the outcome of clinical trials, including unbiased reporting to potential consumers regarding the results, limitations, and availability of the new product
It is expected that students pursuing the Clinical Trials Management Certificate will have a strong science and/or health-care related background. In addition, two years of college level coursework is recommended. The certificate provides the fundamental knowledge to enter the field of clinical research.
REQUIRED: laptop or desktop computer
Required: a PC or Mac, laptop or desktop computer must be used to complete course activities like tests, quizzes, homework, or chats
“I came away with a complete overview of the drug development process.”
“This online course far exceeded other online courses I have taken. I like that the lectures were videos. I have taken online course before and they were all just reading material and very little input from the instructors. It was mostly student conversations and they were all over the place. That is not teaching in my book.”
“I felt like I was in a classroom. I like that [the instructor] takes her time and doesn’t rush through the lectures.”
“I enjoyed learning and looked forward to each and every presentation! [The instructor] does a great job in thoroughly explaining key data for clinical trial management.”
“[This course] was relevant to my current position as a CRA [clinical research associate]. Every module had a reference back to my daily position. This has been very useful.”
“I like the format. [The instructor] is very knowledgeable, and delivers the information as if she is having an informative informal conversation with you. It is perfect for retaining the material, making connections to other disciplines or already known information as well as inspiring thought and further research.”
“I feel passionate about the clinical trial path, and I believe the knowledge I’m gaining will further my goal of pursuing opportunities to enter this field.”
Free to PCS noncredit participants, UD students, and active military or veterans
Special career- and personal branding-focused seminars are available to students enrolled in Professional and Continuing Studies (PCS) programs and UD students, as well as veterans and active military members, at no additional charge. Seminars are also available as an open enrollment seminar series for a $50 fee (fee includes all seminars in the current semester). Topics have included job search tips, interviewing, personal branding, and other career and professional development subjects. Learn more or RSVP now!