Clinical Research Nurse Coordinator

M3 USA

Wilmington, NCOn-siteFull time
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Location
Wilmington, NC
Work style
On-site
Job type
Full time
Posted
Nov 2
2 days ago
Career path

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About the company

M3 USA

Computer software · 201 to 500 employees

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.

M3 USA on LinkedIn

What you'll do

  • 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

What you need

  • 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

Key skills

RN or LPNACLSinfusionsIP handlingsterile compoundinginfusion administrationmedication administrationsource documentationFDA regulationsICH-GCPISO standardscomputer skillscommunicationorganizationattention to detail

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Perks

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance

See full description on company page, apply now

Read the full posting here
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 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 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. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance 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 #LI-Onsite #LI-LB1

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