The Clinical Research Coordinator I (CRC I) is responsible for providing support for clinical research protocols. The Clinical Research Coordinator I will assist the Research Department with all aspects of clinical research. This individual will interact with subjects, clinic and research staff, laboratory staff, and medical professionals.
Responsibilities of the Job & Essential Job Outcomes: * Responsible for administrative functions of research studies. * Ensures compliance with all federal and local agencies including the FDA and IRB. * Supports clinical research activities for multiple research projects. * Recruit subjects for participation in studies, facilitate patient care, prepares the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out. * Reviews protocols and informed consent forms for completeness and compliance with regulations. * Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally according to IATA requirements. * Provide support (including administrative/clerical) and information to subjects, staff, and external sources related to current research projects. * Maintain scheduling of pre-study testing, treatments, outside labs, scans, biopsies, and other tests for all clinical research visits. * Attend meetings and conferences related to research activities. * Maintains appropriate records of clinical activities. * Support clinical research billing reconciliation activities. * Supports the identification of research subjects as they utilize services throughout the MemorialCare Health system. This will include flagging/notifying registration and/or appropriate patient accounts personnel to foster proper research coding and billing pursuant to research billing practices. * Other duties as assigned.
Experience * Two (2) years minimum experience in the field of clinical research required. * Knowledge of clinical trial federal, state and local regulation requirements preferred. * Must have strong MSOffice computer skills, and ability to conduct Internet searches. * Strong project management, analytical, organizational, and problem solving skills. * Superior interpersonal and communication skills. * Demonstrated ability to work on deadlines, set priorities and juggle multiple projects without compromising quality.
Education * Associates degree or equivalent education required. * Bachelor of Science or science-related field is strongly preferred. * ACRP/SoCRA (or equivalent) certification preferred but not required. * Current CITI training preferred. * Must maintain a valid driver’s license and automobile insurance as travel to physician offices and health system locations is required for departmental specific job duties.