Research Nurse Coordinator II - Obstetrics and Gynecology

Position Summary

Research Nurse Coordinator II in Gynecologic Oncology plays a critical role in the coordination and management of clinical trials for patients with gynecologic cancers.

This position is responsible for facilitating study start-up, screening and consenting eligible patients, coordinating protocol-specific procedures, and ensuring compliance with regulatory requirements and study guidelines. Research Nurse Coordinator II serves as a liaison between patients, investigators, sponsors, and multidisciplinary care teams to support the safe and efficient conduct of clinical research.

Additionally, the role involves ongoing patient education, adverse event monitoring and reporting, data collection, and maintaining accurate documentation to ensure trial integrity and adherence to Good Clinical Practice (GCP) standards.

Job Description

Primary Duties & Responsibilities:

• Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
• Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.
• Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
• Works with research team to identify, screen and enroll study subjects.
• Ensures protocol requirements are met including but not limited to: direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry.
• May train and supervise staff assigned to work on the research project(s).
• Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
• Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
• Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary.
• Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced.
• Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
• Provides oversight of administration of study medications and/or study interventions, as appropriate. Administers investigational products in approved settings.
• Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
• Performs other duties incidental to the work described above.