"Clinical Research Nurse Project Manager (Department of Radiation Oncology)"

Job Description Summary

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.

Job Responsibilities

Clinical Research Nurse D (Project Manager)

• 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 applicable), monitoring subjects for post-administration adverse events or reactions. Coordinate activities of the radiation oncology team in caring for participants. Creation of beacon orders and nursing worksheets as needed during study start-up. Provide oversight of administration of medications, chemotherapeutic drugs, cellular immunotherapies, and other treatment agents or study interventions, as appropriate.
• Participate in study team, disease-site group and ongoing protocol training/compliance meetings. If needed, collect, review and report timely, valid, accurate study data within the timelines specified by protocol or Clinical Trials Agreement. Coordination may also include clinical activities such as performing and collecting vital signs, EKG, PK sampling, etc.
• Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, MedOnc, surgical departments, advanced practitioners, triage, inpatient and pharmacy. Provide in-service and support to infusion, CHPS or inpatient staff as appropriate. Provide ongoing service education updates to investigators and study teams that have eligible participants for clinical research trials.
• Responsible for functional supervision of non licensed personnel assigned to work with the nurse. Act in lead capacity in coordination of CRU projects and assist CRU managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support. Participate in working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOPs.
• Additional Duties as assigned.

Supervisor, Clinical Research Nurse (Project Manager)

In addition to the above duties, the Clinical Research Nurse Supervisor will:

• Participate in development of unit based standard operating procedures (SOP) and guidance documents, reviewing clinical sections of new protocols and amendments for logistical feasibility.
• Collaborate with other management personnel in meeting departmental and programmatic objectives.

Qualifications

Clinical Research Nurse D (Project Manager)

Registered Nurse with 4-6 years of experience with Licensure in Commonwealth of Pennsylvania without restriction or limitation required, including 3-5 years of clinical research experience preferred. BSN preferred.
Oncology experience highly preferred.

Supervisor, Clinical Research Nurse (Project Manager)

Registered Nurse with 5-7 years of experience with Licensure in Commonwealth of Pennsylvania without restriction or limitation required, including 3-5 years of clinical research experience preferred. 7-10 years of preferred experience. BSN or MSN preferred.
Oncology experience highly preferred.

Position is contingent upon funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,500.00 - $116,459.00 Annual Rate