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Clinical Research Operations, Post-Baccalaureate Certificate

Start or Enhance a Career in Clinical Research
  • 100%

    Online - Perfect For Working Professionals

  • Faculty

    Have Extensive Research And Industry Experience

Clinical Research Operations Program Overview

Foundational Knowledge & Skills

In this program you’ll gain the foundational knowledge and skills necessary to understand the structure, function, and operations of biopharmaceutical companies, clinical research organizations, clinical study sites, academic medical centers, and other organizations involved in biopharmaceutical clinical trials. Learn more by watching this "Ready, Set, Clinical Research!" video by the Association of Clinical Research Professionals.

Learn To

Explain the marketing approval process for new drugs, biologics and devices and compare the process in the U.S. to other countries and regions

Distinguish each phase of product development in terms of key criteria

Select appropriate regulations and guidelines to guide biopharmaceutical and device product development

Examine and critique approaches for ensuring high quality clinical trial data

Construct a model for forecasting and managing the resources necessary for clinical trials

Find Your Career as:

Supports the monitoring of clinical trials to help ensure research sites follow study protocols and applicable requirements. (Source)

Provides administrative and document management support for study teams, helping organize regulatory binders and site files. (Source)

Assists with funding, compliance and reporting for research programs.

Supports organizations navigating the requirements of federal, state and local regulatory frameworks to ensure compliance with legal and safety standards. (Source)

Sample Courses

A table showing a few sample courses for clinical research operations post-baccalaureate certificate.
CLR 505 Fundamentals of Clinical Research
CLR 501 Clinical Research Monitoring & Ethics
CLR 520 Regulatory Affairs & Quality Management
CLR 550 Clinical Research Trial Design & Data Management
CLR 525 Current Issues in Global Regulatory Development & Management
CLR 530 Project Management in Clinical Research
See The Full Curriculum

How Do I Apply?

A bachelor’s degree preferably in a life science, health care discipline, or mathematics/statistics from a regionally accredited university or college in the U.S. (or its equivalent from a foreign institution based on a four-year program) with a minimum GPA of 2.5.

To apply for admission to this certificate program, the candidate must submit the following:

  1. An application for graduate admission.
  2. Official transcripts of all prior university or college coursework (undergraduate and graduate).
  3. Three letters of recommendations describing the individual’s potential to complete the program (at least one from a current or former employer).
  4. Current professional resume or curriculum vitae.
  5. Application and supplemental documents must be submitted by the published deadline.

These admissions requirements apply only to the graduate certificate program in Clinical Research Operations. Students interested in combining the certificate program with a master’s degree will have to meet all admission criteria for that degree.

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