Responsibilities
- Coordinates with the PI and site team to ensure 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: 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
- 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
- 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 delegated by PI according to study protocol (e.g., vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood)
- Documents procedures 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
- Follows protocol for Investigational Drug/Device Accountability when handling investigational drugs/devices
Work Arrangement
Remote (City/Region)
Additional Information
- Contract/PRN position
- Working hours and responsibilities can vary depending on the associated trial
- Must complete site course requirements including GCP, IATA, OSHA, site SOP review, and study-related courses
- Must cooperate with site management and monitoring efforts
- Must report instances of non-compliance and external inspections/audits immediately to site management
