Job Overview

As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children’s Hospital Medical Center, College of Medicine’s faculty and providers are transforming the world of medicine every day. The Department of Obstetrics and Gynecology is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine?

The Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine is seeking a Clinical Research Nurse to work with the Gynecology Oncology team. This position will coordinate and provide administrative support for clinical research activities and initiatives including participant recruitment, enrollment, and completion of all study and follow-up activities in compliance with the research protocol and existing regulatory frameworks. Provide care to research participants (i.e., routine and complex physical or clinical procedures within scope of licensure and delegation on study) and serve as a resource within area of clinical expertise. Serves as a liaison for designated research protocols, programs or units with internal and external stakeholders such as industry sponsors, contract research organizations. Applies skills to a broad range of different types of studies, navigates resources, and identifies issues needing escalation.

Essential Functions

• Assists the Principal Investigator (PI), researchers and/or clinicians in coordinating all aspects of delegated protocol activities such as participant recruitment, enrollment, completion of research-specific activities, data management with close supervision.
• Assist with coordinating nursing and patient care and/or patient follow-up functions of the clinical study including planning and developing related activities within scope of licensure. 
• Uses basic subject matter expertise in the therapeutic area or clinical research to solve problems with limited supervision.
• Creates source documentation required to support completion of study procedures per protocol and in compliance with applicable regulations and guidelines (ICH-GCP).
• Makes corrections to source documentation or implements corrective actions identified by study monitors/auditors/sponsors per protocol and ICH-GCP when applicable.
• May perform routine limited clinical assessments/procedures such as phlebotomy, blood pressure readings, pulse, and/or structured measures (e.g., NIH Stroke Scale, MME, Quality of Life assessments) etc.
• Acts as a primary point of contact for communication with study participants.
• Schedules study related appointments for participants in clinical and non-clinical settings.
• Accurately enters data from electronic medical records, or paper research charts, into study specific electronic data capture systems, and updates participant status/visits institutional databases for tracking purposes; resolves queries as needed. 
• Supports administrative work, including financials, inventory, scheduling, biospecimen management required for management of studies.
• Prepares & submits study participant-related billing forms or remuneration/reimbursement as required and in accordance with institutional process. Basic understanding of billing compliance, study budget, and invoices for primary study. Under supervision, review invoices for accuracy.
• Comprehends, interprets, and applies human subjects research regulations (i.e. FDA, and ICH-GCP).
• Prepares for, coordinates, and actively participates in site visits (SIVS, IMVs); communicates effectively with sponsors and/or contract research organizations (CROs) with close supervision.
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Associate's Degree.
• Graduation from an accredited school of nursing.

Required Trainings/Certifications

Current valid RN license to practice in the State of Ohio by date of hire.

Required Experience

Two (2) years of clinical nursing experience in a hospital, clinic or similar health care setting.

Additional Qualifications Considered

Additional related experience in women’s health or clinical oncology.

Physical Requirements/Work Environment