Clinical Research Coordinator (CRC) I is an entry level professional title in the Clinical Research Coordinator Family. CRC I's, work closely with study subjects and other research staff, and are involved in most steps of the research trial process. CRC?s participate in clinical research studies conducted by principal investigator(s) including, but not limited to, grant funded research and/or industry sponsored clinical research conducted on site at Cone Health or its affiliated sites; performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. They function under the Principal Investigator?s medical license and cannot perform any tasks that by state or local law require a license to perform. Their work is routine in nature, with assignments provided at a task level, focused on the long term goals of clinical research trial and process. CRC I's have no supervisory responsibilities and work under immediate supervision.
Responsibilities: Assesses patients for protocol eligibility. Confers with study participants to explain purpose of study and obtains informed consent; explains diagnostic procedures and/or treatment plans to alleviate patient and/or family concerns; schedules patient for study procedures; initiates/coordinates drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; codes, evaluates and interprets collected data and prepares appropriate documentation; obtains blood samples, cultures, tissues and other specimens for laboratory analysis. Notifies Principal Investigator and supervisor of subject status.
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Attends Investigator meetings and conferences as required.
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Collects subject data, enters and analyzes data, and compiles reports, adhering to proper research protocols. Prepares documentation, reports, graphs, and other materials. Keeps appropriate logs, tracks participants, and prepares study materials.
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Serves as Study Coordinator for pharmaceutical trials. Accurately reviews all study activities prior to activation; successfully arranges site initiation visits, monitoring visits, and close-out visits; disseminates new information to research staff, pharmacy staff, and principal investigator in a timely fashion. Ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors patients progress to include documentation and reporting of adverse events; recommends corrective actions as appropriate.
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Supports regulatory staff submission of study protocols and amendments, consent forms, and recruiting materials to the Institutional Review Board and department for approval with oversight from supervisor.
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EDUCATION:
Required: Associate?s degree and four years of relevant experience. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification, along with a minimum of two years additional professional experience, will be considered in place of degree. Any degree substitutions are subject to review by committee.
Preferred: Bachelor?s degree and one year of clinical research experience.
EXPERIENCE:
Preferred: List preferred length and type of experience.
LICENSURE/CERTIFICATION/REGISTRY/LISTING:
REQUIRED
Required:
1. Understanding of ICH/GCP guidelines for human research.
2. Understanding of Code of Federal Regulations for Human Subjects.
3. Computer Competency including proficiency in Microsoft Office and EDC systems.
4. Understanding Phases I-IV drug development processes.
5. Technical skills related to the completion of a study visit as required by the protocol.
Obtain Good Clinical Practice certification within 30 days of hire and maintain without lapse.
Obtain Human Subjects Research certification within 30 days of hire and maintain without lapse.
PREFERRED
Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred. Required if candidate does not have Bachelor?s degree
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