Post-Master's Certificate: Clinical Trial Management

SCHOOL OF PHARMACY

About the Certificate

The post-master's certificate in Clinical Trial Management is designed for those who hold an MS in Regulatory Affairs and Quality Assurance and want to keep current with industry issues and meet regulatory requirements for training. The certificate program is also open to professionals with other master's or doctoral degrees.

The graduate certificate in Clinical Trial Management is specifically designed for pharmaceutical and healthcare professionals who actively contribute to the clinical trial process, including physicians, clinical research monitors, investigators and coordinators, and members of Institutional Review Boards (IRBs). Coursework 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. The certificate leads to understanding how clinical trials must be designed and overseen in the pharmaceutical industry, including writing protocols and consent forms, understanding the requirements of Good Clinical Practices, and managing budgets and data.

Time Limit for Certificate Completion: 4 years

Campus Location: Fort Washington and Online

Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

APPLY HERE to the post-master's certificate program.

Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field, including but not limited to an MS in Regulatory Affairs and Quality Assurance. Graduates of Temple University's RAQA program take certificate coursework to keep current with industry issues and meet regulatory requirements for training. Applicants with an advanced science degree from an accredited institution of higher learning other than Temple University must have worked in the pharmaceutical industry for a minimum of three years.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related disciplines.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 12 for graduates of the Temple University Regulatory Affairs and Quality Assurance (RAQA) MS; 15 for students who completed their master's degree at an institution other than Temple University

Required Courses:1

Core Courses
QARA 5459Drug Development3
QARA 5536Good Clinical Practices3
QARA 5537Clinical Trial Management3
QARA 5612Bioethics for Pharmaceutical Professionals3
Elective
Select one from the following: 23
Fundamentals of Pharmacology and Pharmacokinetics
Quality Audit
Statistics for Clinical Trials
Clinical Drug Safety and Pharmacovigilance
Global Clinical Drug Development
Project Management for Clinical Trials
Post-Marketing Safety Surveillance
Pharmacoepidemiology
Benefit Risk Management and Safety Signaling of Healthcare Products
Clinical Data Management (CDM)
Total Credit Hours15

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/certificate-programs/post-masters-certificates/clinical-trial-management

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Program Coordinator

qara@temple.edu

267-468-8560