Clinical Trial Team Members

Get a clearer picture of the basic organization and function of a clinical research team: the roles, regulations, and essential principles that guide
its operations.

There is a role for everyone in this exciting field!

See Course Descriptions Below

Earn a Certificate in Just 3 Months!

This certificate program consists of three courses that will provide you with the tools you need to become successful in today's rigorous marketplace.

  • Clinical Research: Principles, Protocols and Procedures
  • Project Management in Clinical Research
  • Transitioning into a Career in Clinical Research

Each session is taught by an instructor currently working in that topic area. They work at organizations including: Boston Children's Hospital • Centrexion Therapeutics • EMD Serono • EndPointe Clinical Resources, Inc. • Epizyme • Harvard School of Public Health • ImmunoGen • Moderna • Oracle Propel • Careers • QurAlis • Takeda.

Our Clinical Research Certificate Program includes a rigorous curriculum to prepare you for today's competitive marketplace. All courses can be completed in less than three months or you can spread them out over two years. This is a Continuing Education program; it does not have an application process, and offers contact hours. We welcome you to register at any time.

Earn 48 Contact Hours

All Clinical Research courses are being held online via Zoom. Registrations are non-transferrable and final. We do not issue refunds.

What are you interested in?

offering match your criteria

Clinical Research: Principles, Protocols and Procedures
<p>Contact hours for this course: 30</p> <ul> <li>Session 1: Overview of the Clinical Research Process</li> <li>Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process</li> <li>Session 3: Human Subject Protections and Regulatory Oversight</li> <li>Session 4: Clinical Trial Conduct, Monitoring and Record Keeping</li> <li>Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations</li> <li>Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures</li> <li>Session 7: Pharmacovigilance in Drug/Device Development</li> <li>Session 8: Audits &amp; Inspections: Ensuring Clinical Research Quality</li> <li>Session 9: The Role of Data Management in Clinical Research</li> <li>Session 10: Study Budgets and Contracts: Evaluation and Negotiation</li> </ul>
<p>This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.</p>
Project Management in Clinical Research
<p>This course will benefit professionals interested in pursuing a clinical research career by providing a clear understanding of project management principles and processes.Learn industry trends and best practices through real-world examples involving team projects and case studies presented by experts in the industry. Through discussion, presentation, and interaction, this course will broaden the participants' knowledge of the project management process in clinical research.</p> <p>Contact hours for this course: 12</p>
<p>This course will provide an overview of the project management processes: initiation, planning, project life cycle, effective team building, execution, monitoring, tracking, risk management, change management, contingency planning, and close-out processes and procedures.<br /> </p>
Transitioning into a Career in Clinical Research
<p>Contact hours for this course: 6</p> <p>This course is presented in two sessions that will prepare you to confidently embark on your job search. </p> <p><b>Session 1: Computerized Systems in Clinical Research</b></p> <p>Clinical Trial Management System Software Review of Clinical Trials</p> <ul> <li>Electronic Data Capture (EDC)</li> <li>Clinical Trial Management Systems (CTMS)</li> <li>Risk Based Monitoring (RBM)</li> </ul> <p><b>Session 2: Transitioning into and Growing a Career in Clinical Research</b></p> <p>Résumé Basics, Job Search Strategies, and Internet Marketing </p> <ul> <li>Overview of clinical research roles </li> <li>Tips to structure a job search </li> <li>Résumé tips Informational interviewing to accelerate a search </li> <li>Social media tools (LinkedIn) for your search </li> <li>Networking </li> </ul>
<p>This course deals with the challenges related to managing change associated with career transition. Understand the clinical research field as well as your career strengths, career interests, and values. In addition, focus on your uniqueness and its value to yourself and the marketplace. Identify transferable skills and accomplishments that can be used in clinical research. Learn from clinical research experts how to market yourself and how to enter the clinical research arena.<br /> </p>