Clinical Research Nurse C/D (OBGYN - GYN Oncology)

Job Description Summary

Research Nurse C/D is a key clinical research position responsible for coordinating and managing all aspects of clinical trial conduct to ensure the safe, compliant, and efficient execution of research studies. This role involves overseeing the proper reporting of serious and non-serious adverse events to sponsors and regulatory bodies, coordinating the administration and monitoring of investigational products and study medications, and managing all study-related scheduling, documentation, and data collection. Research Nurse C/D works closely with the Principal Investigator to prepare study documents, regulatory submissions, source templates for trial initiation and ongoing operations. Additional responsibilities include assisting with protocol development for logistical feasibility, ensuring accurate transcription of study data into case report forms, coordinating subject visits and procedures, and providing mentorship and support to unit staff. This position plays a critical role in maintaining regulatory compliance, protecting participant safety, and supporting high-quality clinical research.

The Clinical Research Nurse provides input into the development of efficient work flows, helps develop internal budgets for sponsored trials. Attends study meetings develops internal strategies for meeting and exceeding trial enrollment, and assures compliance with regulatory standards.

The Clinical Research Nurse provides oversight for research medication administration, monitors patient care, treatment of side effects and patient status throughout the study period and communicates with research team, including PIs, CRC and regulatory team to ensure patient safety and proper study conduct.

Job Responsibilities

Clinical Research Nurse C:

• Coordinate the conduct of Phase I - IV clinical trials including screening and enrolling eligible subjects, follow GCP guidelines in the conduct of trials, coordinate implementation of research protocols with study and clinical team, collecting and reporting research data, reporting serious adverse events per protocol, coordinate subject care with clinical team, provide coverage and support to other research nurses and coordinators
• Managing subject treatment per protocol, oversight and coordination of research testing, including labs, office visits and radiology exams, provide oversight for research medication administration, monitor patient care, treatment side effects and patient status throughout study period, communicate any research issues to PI
• Participate in research team meetings, assist with staff /study team education, participate in study-related meetings
• Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs
• Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, 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 all investigators and HUP staff that have eligible participants for clinical research trials
• Other duties and responsibilities as assigned

Clinical Research Nurse D:

• Provides clinical oversight for the investigational product administration and ensuring absolute adherence to complex trial protocols; This role is responsible for the technical integration of clinical care and research, managing intricate administration timelines with rigorous post-infusion safety monitoring for adverse events. Beyond bedside coordination, the position serves as the primary clinical lead for the unit by drafting Beacon treatment plans and collaboration with the Center for Human Phenomic Science (CHPS) and investigational pharmacy units to optimize workflows
• 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 screening and enrollment of all study participants. With oversight of the PI, participate in the informed consent and confirming subject study eligibility prior to participation
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies
• 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 protocol implementation to ensure logistical feasibility of all study related procedures and study workflows
• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures. Ensure preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial
• Orient and mentor new unit staff and function as resource for current staff
• Other duties and responsibilities as assigned

*Position Contingent upon funding *

Qualifications

Position requires an individual with excellent oral and written communication skills. The candidate should possess the ability to work independently and also as part of a team. Strong planning, organizational and prioritizing capabilities along with problem solving skills desired. Must be able to work flexible hours. Previous research experience and knowledge of IRB processes, human research protection regulations, and regulatory management preferred. Background in oncology preferred.

• Clinical Research Nurse C: Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation. Bachelor's degree and 2 to 3 years of experience or equivalent combination of education and experience required. BSN preferred
• Clinical Research Nurse D: Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation. Bachelor's degree and 4 to 5 years of experience or equivalent combination of education and experience required. BSN preferred