CLIN TRIALS SCIENTIFIC REVIEW & MONITORING
Duties: Reporting directly to the Manager, DOCM Operation within the Abramson Cancer Center and indirectly to the Chief ACC Compliance Officer- Clinical Research, the Clinical Trials Scientific Review and Monitoring (CTSRMC) Coordinator is responsible for coordination of the initial, ongoing and annual review of protocols assigned to the CTSRMC. This includes pre-reviewing submissions assigned to the convened CTSRMC for completeness and compliance with NCI, federal and institutional regulations/policies; pre-reviewing submissions eligible for expedited review and working with researchers and research staff to resolve issues related to convened or expedited review. He/she prepares meeting agendas; assigns scientifically appropriate protocols to CTSRMC members to review; attends convened meetings; and maintains thorough and complete notes on the discussion. He/she prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in or disapproving research, and a written summary of controverted issues and their resolution. The CTSRMC Coordinator prepares written correspondence to investigators of all CTSRMC actions and decisions. The CTSRMC Coordinator reviews claims of exemptions and expedited reviews as assigned and determines the appropriate level of review and assigns scientific or statistical reviewer as appropriate to the type of study. He/she is the main source of contact between CTSRMC Chair, CTSRMC member/reviewers and investigators. He/she maintains minutes, CTSRMC rosters, CTSRMC electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and ACC SOPs. In contacts with investigators the CTSRMC Coordinator provides guidance on issues related to CTSRMC regulations and CTSRMC actions. The CTSRMC Coordinator participates, as assigned, in research community outreach and training activities; as well as CTSRMC member training and CTSRMC quality improvement initiatives including the review of existing CTSRMC policies and procedures. The CTSRMC Coordinator will interact directly with Penn's IRB to create harmonization of review of study protocols. Additionally, the CTSRMC Coordinator is responsible for maintaining a database of information related to CTSRMC activities and generating reports that are used by ACC leadership and the NCI.
Qualifications: Minimum of a BA/BS in a relevant discipline (biological sciences required) and 3-5 years of experience and knowledge directly related to clinical research or an equivalent combination of education and experience required; detailed knowledge of applicable regulations related to clinical research. Knowledge of scientific review in an academic cancer center is a plus. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.
This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties and responsibilities required of employees assigned to the job.
Reference Number: 40-28079
Salary Grade: 026
Employment Type: Exempt
Org: CC-Cancer Center
Job Family: A-General/Professional Administrative