Research Program Manager

Location: Remote

Part Time

General Description of Services:

The Program Manager will lead the implementation of a newly funded fast track cancer trials. The Research Program Manager is responsible for managing regulatory start-up of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific Clinical Research Programs. These activities will include the development, promotion, direction, and coordination of their assigned areas, including research design, budget, staffing, strategy, IRB submission/management, logistics and other supportive functions to ensure deliverables are met on time and are of high quality.

Deliverables:

• The Program Manager is responsible for creation and oversight of the Management Plan for this team and to ensure timely high-quality execution of all work breakdown structures.
• Cohorts/Sites/oversee protocol development and implementation activities across the trials, which will ensure timely and efficient completion of milestones and deliverables.
• Responsibilities will also include orienting and training research staff in the program, assist with budget development, oversee overall study coordination, and support general operations of the program.
• Work closely with PI's and sponsors to complete all new study submissions to the IRB, Cancer Center, and other required regulatory documents.
• Track each protocol through IRB approval process, evaluate for recurrent problems, develop, and implement systems to decrease delay in the approval process.
• 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 up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
• Responsible for biweekly huddles to check on all assigned areas to ensure deliverables are met on time and are of high-quality.