About This Role
Coordinating clinical trials and supporting patients throughout their participation is the core of this role. The Clinical Research Coordinator ensures all aspects of assigned study protocols are maintained in accordance with Good Clinical Practice, standard operating procedures, and sponsor requirements.
Responsibilities
- Facilitate, maintain, and coordinate the logistical aspects of assigned study protocols with other research staff in accordance with Good Clinical Practice, standard operating procedures, and sponsor requirements
- Provide direct patient care pursuant to a study protocol, including dispensation of investigational medications and performance of study tests under the delegation and direction of the principal investigator or supervising physician
- Attend investigator's meetings, coordinate and attend pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required
- Arrange for procedures and necessary visits performed by external vendors that are necessary to the conduct of the study
- Schedule and lead in-house protocol meetings to review study-related procedures, staffing, and visit flow
- Schedule and coordinate all medical needs and coverage for protocol-related procedures
- Maintain and document all study-related communication, including with the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s), and IRB throughout the clinical trial
- Responsible for giving subject instructions for study participation and serve as the primary contact for subjects by being available to handle study-specific questions, concerns, or events
- Ensure all protocol procedures are completed per study requirements
- Obtain and document all adverse event data on appropriate forms and report adverse event data to the appropriate parties as outlined by the study protocol, regulations, and applicable policies and procedures
- Assure quality and completeness of source documents collected during the course of the study to assist with overall principal investigator review and approval
- Ensure accurate, complete, and timely data entry into CRFs using 100% source documentation verification to assist with overall principal investigator review and approval
- Schedule, lead, and assist with all study-related visits on site and be readily available during visits for applicable corrections, questions, or other study-related or site needs
- Supervise document retention, security, and destruction, where applicable
- Responsible for completing all necessary training for the position, including study protocol-specific training and Health System policies and procedures
- Train other study-specific research staff in collection and reporting of required data, where applicable
