The Clinical Research Coordinator (CRC) functions as the lead coordinator for multiple studies, ensuring that all protocol requirements are met for each enrolled patient. The coordinator is responsible for screening and recruitment of eligible patients, patient education and follow-up, preparation of case report forms, accurate protocol documentation, and drug accountability. The CRC provides professional care through practice, education, and research. The CRC collects and assesses data required by the individual protocol and reflective of the patient's status and appropriately interpret information relative to the patient's age-specific needs.
Essential Job Functions:
Performs electrocardiograms (ECGs), collects blood specimens and processes blood, fecal, urine and other specimens for local analysis or shipment to reference laboratories.
Develops source documents for assigned studies. Manages data collection and ensures all adverse events (AEs) are identified and reported appropriately. Develops informed consent for subjects.
Collects, completes and enters all documentation. Identifies possible AE, side effects, or significant changes in patient's condition and communicates pertinent information to appropriate caregivers.
Provides appropriate patient and family education. Discusses informed consent with patients and verifies the informed consent documentation.
Prepares and submits regulatory documents for submission to the Institutional Review Board (IRB).
Collaborates with the Principal Investigators and other health care professionals in planning approaches to carrying out the requirements of the research study protocol and adherence to research Good Clinical Practice (GPC).
Communicates reports and instructs staff on the purpose, background, and methodology of research study requirements. Discusses and explains the research study protocols. Conducts education of physician and nursing staff on specifics of the protocol, study design and investigational therapeutic agents, procedures and/or techniques specific to the assigned study.
Ensure scientific integrity of data and protect the rights, safety and well-being of patients enrolled in clinical trials.
Performs other duties as assigned or needed to meet the needs of the department/organization.
Certification:
Clinical Research Coordinator Certification | Assocaition for Clinical Research Professionals | Preferred | Employee Provides HR a Copy
Clinical Research Coordinator Certification | Society of Clinical Research Associates | Preferred | Employee Provides HR a Copy
Basic Life Support (BLS) | American Heart Association (AHA) | Within 2 Months of Start Date | Learning Management System
Education:
• Required: Associates - Healthcare
Work Experience:
• Required: A minimum of 3 years Related Experience