Clinical Research Program Specialist (Oncology)

• Under limited supervision of the Sr.
• Clinical Research Program Manager, we are seeking a Clinical Research Regulatory Specialist who will be responsible for managing regulatory maintenance of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific Oncology Clinical Research Program.
• Regulatory maintenance activities include amendment applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management.
• This position requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research.
• Responsibilities will also include orient and train research staff in the program, assist budget development and oversee overall study coordination, and support general operations of the program.

Specific

Duties & Responsibilities

Work closely with Program Manager and PI’s to evaluate study status and complete regulatory requirements, including protocol submissions to IRB and relevant ancillary groups for smooth and timely implementation of protocol amendments. Assist with revision of investigator-initiated studies; assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc. Work closely with PI’s and sponsors to complete all study amendment submissions to the IRB, Cancer Center Cores (such as Sibley TSCRC Lab and IDS Pharmacy), and other required regulatory documents. Track each protocol through Oncology and IRB approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process. For National Cancer Institute trials where Sibley is the lead site, work closely with the project manager and PI to submit the signature institution worksheet for approval, schedule study start-up meeting, maintain communication to ensure high quality of data, timely submission of data, and adherence to guidelines. Conduct internal quality assurance measures, including periodic monitoring and training sessions, to ensure all clinical research faculty and staff within the program are up-to-date with regulatory guidelines, standard operating procedures, and certification requirements. Maintain a continued high level of expertise in institutional databases including Epic, OnCore, eReg, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program. Assist Program Manager with program operations and staff orientation and training – providing suggestions for improved procedures, creating checklists and program-related standard operating procedures. Participate as requested in Cancer Center initiatives such quality-improvement workgroups and committee meetings. Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Ensure that Cancer Center policies, standard operating procedures, and guidelines related to the conduct of clinical trials are followed.