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

University of Pennsylvania

2d•$63,085 - $104,809•Onsite

About The Position

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.

Requirements

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 for Clinical Research Nurse C.
Bachelor’s degree and 4 to 5 years of experience or equivalent combination of education and experience required for Clinical Research Nurse D.
Excellent oral and written communication skills.
Ability to work independently and also as part of a team.
Strong planning, organizational and prioritizing capabilities along with problem solving skills.
Must be able to work flexible hours.

Nice To Haves

BSN preferred for Clinical Research Nurse C.
BSN preferred for Clinical Research Nurse D.
Previous research experience preferred.
Knowledge of IRB processes preferred.
Knowledge of human research protection regulations preferred.
Knowledge of regulatory management preferred.
Background in oncology preferred.

Responsibilities

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
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

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts for health care and dependent care expenses.
Tuition assistance for employee, spouse, and dependent children.
Generous retirement plans (Basic, Matching, and Supplemental).
Substantial amount of time away from work.
Long-Term Care Insurance.
Wellness and Work-life Resources.
Professional and Personal Development resources.
Access to a wide range of University resources, cultural and recreational activities.
Discounts on arts and entertainment, transportation, mortgages, and other goods and services.
Flexible work hours.
Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia.
Adoption Assistance.