CLINICAL RESEARCH CERTIFICATE PROGRAM

The online Certificate in Clinical Research is a post-baccalaureate,  non-degree certificate for any clinician with a baccalaureate degree who is seeking a focus in research and is interested in advancing their knowledge and skills as clinical research coordinators and quality assurance managers. The Clinical Research certificate consists of 17 credits, 12 didactic and 5 practicum credits, all of which can be completed in two college semesters. The curriculum builds upon the students’ existing research knowledge and skills to enhance their expertise to conduct and coordinate clinical research studies following federal regulations and Good Clinical Practice (GCP). In addition, courses have been selected and developed to satisfy the certification eligibility requirements of the Association of Clinical Research Professionals. Graduates can broaden their marketability in a variety of clinical research settings.

Graduates of the Certificate in Clinical Research may be eligible for National Certification as a Certified Clinical Research Coordinator by the Association of Clinical Research Professionals (ACRP) after meeting all other CRC requirements and successful completion of the Clinical Research Coordinator (CRC) Certification Exam

PROGRAM STUDENT LEARNING OUTCOME

  • Describe the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance.

  • Demonstrate an understanding of the informed consent process in clinical trials.

  • Explain the measures taken during site evaluation, set-up and initiation to ensure that the conduct of clinical trials complies with the protocol.

  • Explain the processes involved in establishing international standards and technical requirements for Good Clinical Practice.

  • Discuss the key responsibilities of the Sponsor, Investigator, Monitor and the Study Team in conducting a successful clinical trial.

  • Discuss the role of clinical trial design in clinical research, and explain the relevant legal documents and guidelines relating to clinical trial design.

  • Appraise the procedures to be conducted to close a trial at each investigational site, when the requirements of the protocol have been fulfilled, or if continuation of the trial is considered inappropriate.

  • Manage the application of the main guidelines of Good Clinical Practice in the workplace.

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