Clinical Trial Registered Nurse - RN

Position Summary

This position provides and coordinates clinical care for research subjects. This position has a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, and accuracy of data collection, data recording and follow‑up. This position also engages in study procedures including administration of investigational drugs, detailed clinical assessments including adverse event assessments, and performing laboratory tests. Additional nursing care may be necessitated by the response of the participant to the study intervention. This position is responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory and institutional requirements and reporting. This position will support the Principal Investigator and Research team for departmental studies under minimal supervision.

Position Duties

Provides nursing care to research study patients, including performing and/or scheduling medical tests within the scope of nursing licensure (laboratory tests, vital sign readings, imaging studies, cardiac and/or pulmonary function tests, psychological evaluations), administering study medications, performing patient assessments during clinic visits to determine presence of side effects, notifying the principal investigator and responding to findings or issues, providing patient education and medical information, and documenting medical data in patient chart.

Ensures assigned studies are conducted in accordance with FDA, OHRP, and GCP guidelines by reviewing all regulatory requirements, completing and submitting documents to the appropriate IRB and institutional committees, maintaining compliance with current and accurate documentation in the regulatory binders, explaining the study purpose and parameters to participants, and coordinating informed consent and entry into studies, ensuring all inclusion and exclusion criteria are met.

Coordinates the process for opening new studies by obtaining necessary background material, presenting findings to the attending physician or principal investigator, completing feasibility questionnaires, circulating confidentiality disclosure and trial agreements, creating study budgets, and developing workflow procedures for the study team based on protocol.

Completes all tasks required by study sponsors, including providing regulatory documents, completing case report forms and data entry, maintaining source documentation, tracking and reporting adverse events, coordinating research monitor visits, and responding to data queries.

Participates in recruitment and selection of study participants, coordinating and participating in informed consent and entry processes to ensure criteria are met.

Reviews monthly financial reports, participant billing, expenditures and revenue, maintains inventory levels of supplies and equipment, initiates requisitions for replacements, and maintains equipment to ensure continuous operational efficiency.

Participates in professional development programs to maintain awareness of current methodologies, practices, and philosophies relevant to the patient population and research area.

Performs miscellaneous job‑related duties as requested.

#J-18808-Ljbffr