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M3 Wake Research · 9 hours ago

Clinical Research Coordinator - PRN/ Contractor

Sandy Springs, GA

Contract

Onsite

Entry, Mid Level

2+ years exp

M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical and clinical research organizations. The Clinical Research Coordinator will support site-based trial execution, ensuring compliance with regulations and managing study documentation while performing delegated procedures and assisting with participant visits.

Health CareMedicalPharmaceutical

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