Clinical Research Nurse Supervisor

Job Description Summary

The Clinical Research Nurse Supervisor will report directly to the Director of RadOnc CRU. Provides leadership in the coordination of IIT and federal or industry sponsored clinical studies/trials. Oversees study/trial start-up, conduct, and close-out. In charge of Beacon built/order, AE/SAE assessment. Ensure study/trial data integrity and regulatory compliance with GCP guidelines, Federal/FDA regulations, and institutional/sponsor requirements. Supervise CRCs and CRNs as assigned. Supporting project timelines & preparing for monitoring and audit visits.

Job Description

Job Responsibilities

• Work with CRU leadership and Principal Investigators to initiate new IITs and industry-sponsored clinical trials in the department. Manage assigned clinical studies and Phase I-IV clinical trials. Assist with protocol development to ensure logistical feasibility of study related procedures and work-flow. Prepare study SOP, documents (e.g., visit guides, source document), subject binders, tracking logs for study start up. Assist with new study budgeting and manage active study invoicing as appropriate.
• Train and Supervise CRCs and CRNs as assigned. Determine workload and assignments for your team. Responsible for or participate in the hiring and performance management of staff. Provide training and oversight to network sites as assigned. Orient and mentor new unit staff and function as resource for current staff.
• Oversee study/trial implementation, including treatment, follow-up visits and procedures, data collection, concomitant medications, and adverse events, etc. Ensure proper documentation, assessment, and reporting of AE/SAEs to study/trial Sponsor and all applicable institutional or study related committees according to regulations and requirements. Prepare for and participate in monitoring or audit visits conducted by study sponsors, CROs, the FDA, the University of Pennsylvania's OCR, ACC DOCM, and other regulatory groups.
• Coordinate the administration of the investigational product and study related medications including creation of beacon built/orders and nursing worksheets, obtaining orders, administration dates, monitor the administration of study related medications and subject safety. Work with clinical team in caring for participants as appropriate.
• Participant in study team, disease-site group and ongoing protocol training/compliance meetings. Address queries in timely manner. Other responsibilities may include training, performing, and collecting vital signs, EKG, PK sampling, etc.
• Communicate with multidisciplinary teams to ensure study activation and implementation per protocol. Provide education updates to investigators and trainings to study teams. Attending standing and adhoc meetings as required.
• Other duties and responsibilities as assigned.

Qualifications

BSN degree and 5+ years or MSN with 3+ years of experience with Registered Nurse and Licensure in Commonwealth of Pennsylvania without restriction or limitation required.

Position is contingent upon funding.

Position is hybrid eligible after successful completion of introductory period and 6 months of service.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$89,500.00 - $116,459.00 Annual Rate