Clinical Research Nurse Coordinator

Wake Research•Wilmington, NC

6d•Onsite

About The Position

M3 Wake Research is hiring a Clinical Research Nurse Coordinator to support clinical trials at its Wilmington, North Carolina site. This on-site role performs trial-related procedures as directed by the Principal Investigator (PI), including handling and administering investigational products. The coordinator manages and supports the daily work of studies and collaborates with the Investigator team, sponsors, and site staff to keep study activities on track and compliant. The role includes following study protocols and timelines; conducting infusions and other delegated procedures; educating patients; supporting informed consent; reviewing medical and medication histories; maintaining accurate study records; and helping meet enrollment goals. The coordinator also communicates with sponsors, CROs, vendors, participants, and caregivers, attends study visits and meetings, and reports non-compliance or external audits to site management.

Requirements

Current RN or LPN license in the state of North Carolina.
Current ACLS provider card.
At least 1 to 2 years of experience performing infusions.
Working knowledge of investigational product handling, sterile compounding, infusion administration, medication administration, and source documentation in a research setting.
Solid understanding of FDA regulations, ICH-GCP, and ISO standards.
Comfort with clinical and sponsor systems and strong computer skills.
Strong communication, organization, and attention to detail.
Ability to work independently and as part of a team.

Nice To Haves

Ideally, 1 to 2 years of clinical research-related experience.

Responsibilities

Follow assigned protocols, study procedures, timelines, and inclusion and exclusion criteria.
Perform infusions as required by clinical trial protocols.
Handle, prepare, administer, and track investigational products, including inventory and accountability.
Lead patient consultations and provide education in an outpatient setting under the direction of the PI.
Participate in the informed consent process and ensure amended consents are properly implemented.
Perform delegated study procedures such as vital signs, EKGs, phlebotomy, pulmonary function testing, and sample processing, and document them accurately in source records.
Review medical and concomitant medication histories and help complete case report forms.
Keep regulatory binders, source documents, and the Delegation of Authority Log organized and audit-ready.
Partner with the recruitment team to meet enrollment goals.
Communicate with sponsors, CROs, vendors, participants, and their caregivers.
Attend PSVs, SIVs, IMVs, COVs, and investigator meetings, with some travel as needed.
Report non-compliance or external audits to site management promptly.