Clinical Research Nurse Project Manager; Department of Radiation Oncology

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Clinical Research Nurse Project Manager (Department of Radiation Oncology)

Clinical Research Nurse D

The Clinical Research Nurse Project Manager will support all aspects of clinical research activities in the CRU that requires RN involvement, will directly report to the Director of Clinical Research. This position provides leadership in the coordination of clinical trials & projects. Oversees study approvals, participant enrollment & consent, visit scheduling, medication administration, data collection, & regulatory compliance with institutional & sponsor requirements.
Position is contingent upon funding.

• Collaborate with Research Team and Principal Investigators to initiate study procedures for new investigator‑initiated trials (IITs) and industry‑sponsored clinical trials. Serve in a Clinical Research Nurse (CRN) role to coordinate, implement, and manage assigned clinical studies and Phase I–IV clinical trials. Assist with protocol development to ensure logistical feasibility of all study related procedures and study work‑flow. Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up.
  
  Assist with new study budgeting and manage active study invoicing as appropriate.
• Provide direct supervision & management to Clinical Research Coordinator (CRC) s within the assigned team and any CRNs if applicable. Determine workload and assignments for team staff. Responsible for or participate in the hiring and performance management of staff. Provide training and oversight to network sites on the assigned studies. Orient and mentor new unit staff and function as resource for current staff.
• Manage scheduling and coordination of subject study specified treatment, follow‑up visits and procedures. Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events. Ensure proper evaluation, documentation, reporting of SAEs and AEs of studies to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies.
  
  Prepare for and participate in audits conducted by study sponsors, CROs, the FDA, the University of Pennsylvania’s CTSRMC, and other regulatory groups.
• Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as…