CRC Level 1

Clinical Research Coordinator I

Develop and maintains proper skills to comply with the protocol, federal regulatory requirements, internal SOP's, and COG's
* Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
* Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
* Communicates with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
* Attends investigator meetings.
* Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
* Accurately collects study data via source documents/progress notes as required by the protocol.
* Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
* Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
* Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
* Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
* Dispenses study medication at the direction of the Investigator.
* Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
* Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
* Addresses all queries or data clarifications within 48 hours of receipt.
* Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
* Reports protocol violations and significant deviations to the Manager of Clinical Operations.
* Establishes relationships with volunteers, and participates in patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process.