Clinical Research Nurse Coordinator

Wake Research; Wilmington (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance

Job summary

M3 Wake Research is seeking a Clinical Research Nurse Coordinator to support trials at our Wilmington, NC site. You will perform protocol-directed procedures, dispense investigational product, and coordinate daily study activities under the Principal Investigator.

Work with investigators, sponsors, and site staff to ensure compliance with FDA regulations, ICH-GCP, ISO standards, and IP handling. Contribute to enrollment goals while maintaining audit-ready records.

Qualifications

• Currently licensed RN or LPN in NC.
• ACLS provider card.
• 1–2 years of infusion experience.
• Ideally 1–2 years of clinical research.
• IP handling, sterile compounding, infusion administration, and source documentation in a research setting.
• Solid understanding of FDA regulations, ICH-GCP, and ISO standards.
• Comfortable with clinical and sponsor systems and strong computer skills.
• Strong communication, organization, and attention to detail, and able to work both independently and as part of a team.

Responsibilities

• Follow study protocols, 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 PI.
• Take part in the informed consent process and implement amended consents.
• Perform delegated procedures such as vitals, EKGs, phlebotomy, pulmonary function testing, and sample processing.
• 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, and participants and their caregivers.
• Attend PSVs, SIVs, IMVs, COVs, and investigator meetings, with some travel as needed.
• Report any non-compliance or external audits to site management right away.

Skills

Infusions

IP handling

Clinical research

ACLS

Communication

Attention to detail

Teamwork

Education

RN or LPN license in NC

Job description

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for aClinical Research Nurse CoordinatoratWake Research,an M3 company. This is an on-site role at our Wilmington, NC site.

Job Description

M3 Wake Research is looking for a Clinical Research Nurse Coordinator (CNC) to support our mission by performing trial-related procedures as directed by the Principal Investigator, including accurate dispensing and dosing of investigational product. While the Principal Investigator is responsible for the overall conduct of the trial, you’ll manage, support, and coordinate the daily work that keeps the study on track, and you’ll play a critical role in how it runs. You’ll work closely with the Investigator team, sponsors, and site staff to make sure every part of the study is compliant.

What you’ll do:

• Follow assigned protocols, including 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 PI
• Take part in the informed consent process and make sure amended consents are properly implemented
• Perform delegated study procedures such as vitals, EKGs, phlebotomy, pulmonary function testing, and sample processing, and document them accurately in source
• 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, and participants and their caregivers
• Attend PSVs, SIVs, IMVs, COVs, and investigator meetings, with some travel as needed
• Report any non-compliance or external audits to site management right away

Qualifications

• Currently licensed as a RN or LPN in the state of NC
• Current ACLS provider card
• At least 1 to 2 years of experience performing infusions
• Ideally, 1 to 2 years of clinical research related experience
• Working knowledge of IP handling, sterile compounding, infusion administration, medication administration, and source documentation in a research setting
• Solid understanding of FDA regulations, ICH-GCP, and ISO standards
• Comfortable with clinical and sponsor systems and strong computer skills
• Strong communication, organization, and attention to detail, and able to work both independently and as part of a team

Additional Information

About M3:

M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization

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