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

About the role

The Clinical 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.

Responsibilities

• Clinical Research Nurse C:
  • Coverage and support to other research nurses and coordinators
  • Attends study meetings
  • Develops internal strategies for meeting and exceeding trial enrollment
  • Ensures compliance with regulatory standards
  • Provides input into the development of efficient work flows
  • Participates in research team meetings
  • Provides in-service and support to infusion, CHPS or inpatient staff as appropriate
  • Provides ongoing service education updates to all investigators and HUP staff
  • Develops and maintains ongoing communication with the clinical teams
  • Provides coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs
  • Provides clinical oversight for the investigational product administration and ensuring absolute adherence to complex trial protocols
  • Manages intricate administration timelines with rigorous post-infusion safety monitoring for adverse events
  • Assists with protocol implementation to ensure logistical feasibility of all study related procedures and study workflows
  • Meets with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures
  • Ensures preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial
  • Orients and mentors new unit staff and functions as a resource for current staff
• Clinical Research Nurse D:
  • Provides clinical oversight for the investigational product administration and ensuring absolute adherence to complex trial protocols
  • Serves as the primary clinical lead for the unit by drafting Beacon treatment plans and collaborating with the Center for Human Phenomic Science (CHPS) and investigational pharmacy units to optimize workflows
  • Manages scheduling and coordination of subject study specified treatment, follow-up visits and procedures
  • Manages collection of data from source documents pertaining to study visits and transcribes to case report form, including concomitant medications and adverse events
  • Ensures proper screening and enrollment of all study participants
  • With oversight of the PI, participates in the informed consent and confirms subject study eligibility prior to participation
  • Ensures 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
  • Prepares 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
  • Affords assistance with protocol implementation to ensure logistical feasibility of all study related procedures and study workflows
  • Meets with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures
  • Ensures preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial
  • Orients and mentors new unit staff and functions as a resource for current staff

Qualifications

• 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

Skills

• Excellent oral and written communication skills
• Strong planning, organizational and prioritizing capabilities
• Problem solving skills
• Ability to work independently and as part of a team
• Flexible working hours
• Previous research experience and knowledge of IRB processes, human research protection regulations, and regulatory management
• Background in oncology

Benefits

The University of Pennsylvania 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.