Clinical Research Nurse C/D (OBGYN - GYN Oncology)
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University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Nurse C/D (OBGYN - GYN Oncology) Job Profile Title Clinical Research Nurse C 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 Description 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 cl