The Post-Master's Certificate in Clinical Trial Management provides the tools and information needed to understand how clinical trials must be designed and overseen in the pharmaceutical industry, including writing protocols and consent forms, delving into the requirements of the Good Clinical Practices, and managing budgets and data.
This five-course certificate is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the clinical trial process, including physicians, clinical research monitors, investigators, and coordinators, or members of Investigational Review Boards (IRBs). It provides the tools and information needed to understand the basis for new drug discovery, the design and implementation of the clinical protocol, its conduct and effective monitoring strategies, and the auditing of data to ensure the integrity of the trial. Specific courses emphasize protocol development, the bioethics of clinical research and the protection of the human research subject, the informed consent form and process, clinical operations, and the role and responsibilities of the key personnel – the IRB, sponsor, monitor, CRO, and the clinical investigator. The GRE is not required for the Clinical Trial Management Certificate.
Required courses include:
- Drug Development (5459)
- Good Clinical Practices (5536)
- Clinical Trial Management (5537) or Global Clinical Drug Development (5539)
- Bioethics for Pharmaceutical Professionals (5612)
- Statistics for Clinical Trials (5497) or Clinical Data Management (5618) or Project Management for Clinical Trials (5547) or Clinical Drug Safety and Pharmacovigilance (5538) or Project Management for Clinical Trials (5547) or Risk Management and Safety Signaling in Healthcare Products (5578).
Graduates of the MS in RAQA at Temple must successfully complete four courses beyond those completed for the MS. Students with MS degrees from other institutions must complete five courses. Temple graduates must apply for the post-master's certificate before starting the courses.
Application Information for RAQA Post-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Post-Master's Certificates
- Contact the RAQA office to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Post-Master's Certificates
- A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- You must apply before starting the program on the Graduate Application Portal.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to qara@temple.edu. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
- Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
- Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details.
Questions?
Contact our office directly to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.