Clinical Research Coordinator - Temporary Assignment

Wake Research•Dallas, TX

13d•Onsite

About The Position

A Clinical Research Coordinator (temporary) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: 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.

Requirements

Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Successful completion of the GCP certification.
Phlebotomy and EKG experience.

Nice To Haves

+2 years of CRC experience is preferred.
Bilingual - Spanish preferred.

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.