M3 USA · 1 day ago
Clinical Research Coordinator - PRN/ Contractor
Sandy Springs, GA, USA
Full-time, Contract
Onsite
Entry, Mid Level
2+ years expM3 Wake Research, an M3USA Company, is a leading integrated network of clinical research sites. They are seeking a Clinical Research Coordinator to support site-based trial execution, ensuring compliance with regulations and managing study documentation and participant visits.
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Responsibilities
Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses
Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management
Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures
Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria
Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials
Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc
In accordance with site’s informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed
Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents
Obtains/reviews participant’s medical history, concomitant medication history and inclusion/exclusion criteria review
Assists with timely completion of case report forms, if appropriately delegated/trained
Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability
Assists fellow co-workers with studies as time and ability permits
Qualification
Required
Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
Successful completion of the GCP certification
Phlebotomy and EKG experience
Preferred
+2 years of CRC experience is preferred
Benefits
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
Company
M3 USA
M3 USA believes in growth, for our company and for the people who drive it's success.
201-500 employees
H1B Sponsorship
M3 USA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Marina Lamitina, MBA, MA
Chief Human Resources Officer
Shivani (Murty) Sitaram, SHRM-CP
Human Resources Business Partner
Recent News
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2022-02-04
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