Clinical Research Nurse Coordinator

M3USA•Wilmington, NC

6d•Onsite

About The Position

M3 Wake Research is hiring a Clinical Research Nurse Coordinator at Wake Research in Wilmington, North Carolina. This is an on-site role supporting clinical trials by performing trial-related procedures as directed by the Principal Investigator (PI), including dispensing and dosing investigational products. The coordinator manages and supports the day-to-day work of studies and collaborates with the Investigator team, sponsors, and site staff to ensure study activities comply with requirements. The role includes following study protocols and timelines, conducting infusions and other delegated procedures, providing patient education, supporting informed consent, maintaining accurate study documentation, and helping meet enrollment goals. The coordinator also communicates with sponsors, CROs, vendors, participants, and caregivers; attends study visits and meetings, with some travel as needed; and promptly reports non-compliance or external audits to site management.

Requirements

Currently licensed as an RN or LPN in 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, with the 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/exclusion criteria.
Perform infusions as dictated by the clinical trial protocol.
Handle, prepare, administer, and track investigational product, including inventory and accountability.
Lead patient consultations and education in an outpatient setting under the direction of the Principal Investigator.
Participate in the informed consent process and ensure amended consents are properly implemented.
Perform delegated study procedures, including vital signs, EKGs, phlebotomy, pulmonary function testing, and sample processing, and accurately document them in source records.
Review medical and concomitant medication history 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.