CLINICAL REGULATORY COORDINATOR
Duties: With minimal supervision, participate in the coordination of Phase I-IV clinical trials. Prepare and process all regulatory documentation through IRB, CTSRMC, FDA and all applicable regulatory review committees - including new submissions, continuing reviews, amendments, adverse events and reportable events. Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA. Organize and maintain all regulatory affairs documentation/files as required. Resolve regulatory and data queries as required. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, site group meetings, and ongoing protocol training/compliance meetings. Assist in the development of investigator-initiated research protocols, FDA IND applications and annual reports, and in the development/maintenance of study specific case report forms and source document tools. Assist with regulatory/compliance guidance/oversight of investigator-initiated trials and investigator-initiated multi-site trials. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Qualifications: Bachelor's degree and 2-4 years of related experience or an equivalent combination of education and experience required. Must have knowledge of IRB and human research protection regulations. Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently.
Reference Number: 40-25061
Salary Grade: 026
Employment Type: Exempt
Org: DM-Translational Medicine and Human Genetics
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research