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.

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.

Clinical Research Nurse D:

• Provides clinical oversight for the investigational product administration and ensuring absolute adherence to complex trial protocols
• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures.
• Ensure proper screening and enrollment of all study participants.
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees
• Ensure preparation of study related document templates
• Assist with protocol implementation to ensure logistical feasibility of all study related procedures and study workflows
• Orient and mentor new unit staff and function as resource for current staff

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