Clinical Trials Management Certificate
Explore new opportunities as a clinical trials professional
- New! Offered online—Beginning in Fall 2015, this program will be offered in a completely online format and will take 14 weeks to complete.
- Gain a complete perspective of clinical trials management
- Enter this challenging field, advance in your job, or build useful new skills
- Interact with industry and health care professionals
- Power up your career with a leadership development e-module and customized career enrichment options.
Who should participate?
This certificate is appropriate for those professionals who have a strong science and/or health-care related background, including, but not limited to, nurses, pharmacists, medical technologists, and physicians. Most employment opportunities in the industry require a minimum background of a bachelor’s degree. Two years of college level education is recommended for admission into the certificate program.
Hear from program grads
About the field
Diverse career opportunities
The field of health care has never been so dynamic and challenging as it is today with many diverse career opportunities that fall under the health-care umbrella. Clinical research is one such opportunity. The discovery and approval of new drugs will continue to revolutionize the health-care industry for years to come.
The Clinical Trials Management Certificate is one way to help prepare interested professionals for a new career in pharmaceutical and device development. This program will introduce individuals to the knowledge and skills that are needed to enter the exciting field of clinical research.
Joann DiLiberto, RN, MS Senior Study Delivery Operational Specialist, AstraZeneca
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 health-care backgrounds.
A clinical research professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, quality assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.
Clinical trials professionals are employed in a variety of settings:
- Pharmaceutical companies
- Biotechnology organizations
- Medical device companies
- Contract research organizations
- Educational institutions
- Independent contractors
Michele Welch, RN, MSN
Michele Welch is currently the director of the regional monitoring organization at Actelion Pharmaceuticals. She has over 20 years’ experience in global pharmaceutical drug development at several large pharmaceutical companies, including AstraZeneca, where she was director of the 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 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.
The certificate program in Clinical Trials Management provides a broad overview of key competencies necessary for a successful understanding and conduct of the new product development process in today’s environment. The program covers the logistics of site management, including start up, maintenance, and close out, with the corresponding collection and management of data. The program emphasizes the regulatory, privacy, and compliance issues critical to the successful approval of a new product for launch. The issues that the current environment poses for new product development, both in the U.S. and globally, are discussed and the students, through team simulations and interactions with experts in the field, are challenged to find ways to minimize their impact on new product delivery. The various roles integral to the development process are presented with focus on how they interrelate in a team model. The role of the trial subject/patient is described, with emphasis on safety and benefits potentially achieved in investigative trial participation.
The curriculum of the Clinical Trials Management Certificate covers core concepts consistent with the Academy of Clinical Research Professionals certification exams, a valuable credentialing opportunity for clinical research professionals.
To earn the Clinical Trials Management Certificate, all three of the following modules must be successfully completed with a grade of “C” or above.
- Development: Setting Up the Environment for Success
- Implementation: Carrying Through the Plan
- Integration: Creating the Package
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
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
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
The cost of the certificate program is $2,100, due at the time of registration.
The Clinical Trials Management Certificate is offered in a completely online format.
Technology requirements include:
- Access to a computer with a high-speed (broadband) Internet connection
- Software (all available by free download)
- Adobe Flash, a free browser plug-in, to view online lectures. (Click here to download and install Flash.)
- Adobe Reader, a free software tool, needed to view course presentations. (Click here to download and install Adobe Reader if you don’t already have it.)
- Mozilla Firefox is the recommended browser. Other browsers such as Chrome, Safari or Internet Explorer are not fully compatible with the learning management system used in this course and are not supported.
Viewing course modules on your mobile device:
- The online modules for this program can be viewed on a mobile device.
- Click here for browser recommendations and other compatibility notes.
It is expected that students entering the 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.
Development: Setting Up the Environment for Success (September 14-October 19, 2015)
- Drug Device Phases (Instructor: Michele Welch)
- Ethical Considerations (Instructor: Michele Welch)
- U.S. Regulatory Affairs (Instructor: Michele Welch)
- Legal Implications (Instructor: Robb Giddings)
- Pre-initiation Visits (Instructor: Michele Welch)
- Project/Site management (Instructor: Michele Welch)
Implementation: Carrying Through the Plan (October 26-November 16, 2015)
- Monitoring Visits (Instructor: Michele Welch)
- Data Management (Instructor: Joanne Meredith)
- Drug/Device safety (Instructor: Wenda Brennan)
Integration: Creating the Package (November 23-December 14, 2015)
- Closeout Visits (Instructor: Michele Welch)
- Auditing (Instructor: Kathy Papp)
- Medical Communications (Instructor: Curt Johnson)
- Marketing a Product (Instructor: Julia Bayuk)
This certificate can be earned in approximately three months.
Early bird discount
UD alumni and student discount
A 15% discount available to graduates of UD undergraduate and graduate degrees, UD certificate programs and Professional and Continuing Studies noncredit programs; as well as current matriculated UD students (part-time or full-time). To apply discount, call 302-831-7600.
A 15% discount available to active members of the military as well as veterans. Please provide appropriate ID when registering. To apply discount, call 302-831-7600 or 1-866-820-0238.
Enroll two or more individuals from one business or organization in a noncredit professional development program and benefit from a 15% reduction in the total cost of registration. Individuals must register at the same time. To apply discount, call 302-831-7600.
Receive a 10% discount if you register and pay in full at or before the Certificate Information Session.
Business association membership discount
Are you (or your employer) a member of a business association, like the Delaware State Chamber of Commerce? View the list of partner discounts.
Continuing Education Scholarships
Partial funding for a limited number of qualified applicants with financial need. Transcript and proof of income required. For details, contact Debbie Farris, firstname.lastname@example.org or 302-831-2743. Download the application with instructions.
Economic Competitiveness for Delawareans Scholarship
Applicant must be a high school graduate, a currently unemployed Delaware resident collecting unemployment insurance, and financially able to pay half of program cost. Download further details with application.
Delaware Workforce Investment Board
Individual Training Account (ITA) grants for continuing education noncredit courses. Applicants may be dislocated workers, unemployed because of layoffs or because their employer went out of business, or may be employed with income below Family Income Guideline thresholds. Learn more by speaking with a case manager at a Delaware Department of Labor One Stop Service Center. After grant approval, contact the UD noncredit registrar at 302-831-7600.
Governor’s Education Grant
The Governor’s Education Grant provides up to $2,000 to qualified individuals. For details or to apply, visit the Governor’s Education Grant for Working Adults or the Governor’s Education Grant for Unemployed Adults. For details, contact Debbie Farris at email@example.com or 302-831-2743.
This program is approved by the Delaware State Approving Agency for the training of veterans. Contact the Veterans Affairs regional office at 1-888-442-4551 to determine your individual eligibility. When eligibility is determined, please submit a copy of your DD-214 (if discharged, VA 22-1990 (if active), or NOBE (if active Reserve or National Guard) when you register for one of the eligible certificate programs.
A credit card payment plan is available for this program, with a $50 payment plan fee added to the cost of the certificate program. Specific terms such as the required number of scheduled payments varies by program. For details call 302-831-7600 or write to firstname.lastname@example.org.
Private loans may be an option to pay for noncredit programs, for example, obtaining a loan from your bank or credit union. One option may be the Sallie Mae Smart Option Student Loan (select University of Delaware Noncredit, code 00143198 from the drop-down menu). To speak with a UD ACCESS advisor about loan options call 302-831-2743 to make a phone or in-person appointment.
Taxpayers who pay qualified tuition and related expenses to an eligible educational institution may be able to claim tax credits or deductions on their federal income tax. Call 302-831-1138 for a “Confirmation of Tuition” letter, which can be provided by the University of Delaware noncredit registrar. Please note the registrar’s office does not supply a Form 1098-T, as the Confirmation of Tuition represents accepted documentation.