REGULATORY AFFAIRS COORDINATOR B/C

Location
Philadelphia
Posted
Jul 15, 2017
Institution Type
Four-Year Institution

Duties: Regulatory Affairs Coordinator B: With minimal supervision, participate in the coordination of Phase I-IV clinical trials. Prepare and process all regulatory documentation through the 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, disease site group meetings, and ongoing protocol training/compliance meetings. Assist in the development of investigator-initiated research protocols, assist with FDA IND applications and annual reports, and assist 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. Support compliance and quality assurance activities within the ACC CRU.

Regulatory Affairs Coordinator C: Independently participate in the coordination of Phase I-V clinical trials. Prepare and process all regulatory documentation through the 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, disease site group meetings, and ongoing protocol training/compliance meetings. Oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools. Provide direct regulatory/compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site trials. Oversee compliance and quality assurance activities within the ACC CRU.

Qualifications: 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; knowledge of IRB and human research protection regulations.

Coordinator B: Bachelor's degree and 2-4 years of related experience or equivalent combination of education and experience required.

Coordinator C: Bachelor's degree and 4-6 years of related experience or equivalent combination of education and experience requied.

Reference Number: 40-26087

Salary Grade: 026/027

Employment Type: Exempt

Org: CC-Cancer Center

Special Requirements:

Job Family: I-Technical/Professional Research