Clinical Research Coordinator II (On-site)

M3USA•Raleigh, NC

1d•Onsite

About The Position

The Clinical Research Coordinator II (CRC II) is an experienced research professional who works collaboratively with clinical research site management and the Principal Investigator (PI) to support the successful execution of clinical trials. While the PI maintains overall responsibility for the conduct of the study, the CRC II independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency. The CRC II also serves as a resource and mentor to research staff and contributes to study oversight, workflow optimization, and team development.

Requirements

Clinical Research Coordinator with 2+ years of experience
Phlebotomy experience is highly preferred
Excellent verbal & written communication skills
Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
Extensive clinical trial knowledge through education and/or experience
Successful completion of GCP Certification and Advanced CRC preferred
Detail-oriented
Familiarity with the Code of Federal Regulations as they pertain to human subject protection
Strong interpersonal skills

Nice To Haves

Phlebotomy experience is highly preferred
Successful completion of GCP Certification and Advanced CRC preferred

Responsibilities

Assist the Investigator in screening and reviewing potential study participant eligibility in accordance with protocol requirements
Maintain accurate and timely case report forms, source documentation, study charts, and regulatory documentation
Provide mentorship, training, and day-to-day oversight to Clinical Research Coordinators and Research Assistants
Ensure all clinical research activities are conducted in compliance with study protocols, GCP guidelines, sponsor requirements, and applicable laws, regulations, policies, and procedures
Collect, review, and enter study data with a high degree of accuracy and attention to detail
Support management in the candidate interview, selection, onboarding, and shadowing processes for new hires
Assist with study start-up activities, ongoing study maintenance, and close-out procedures across assigned studies and team initiatives
Collaborate with investigators, sponsors, CROs, and internal departments to facilitate efficient study operations and issue resolution
Demonstrate the ability to independently prioritize workload and adapt to changing study needs and assignments
Serve as a resource for team members regarding study processes, protocol requirements, and site procedures