Coordinates assigned clinical research studies by performing diverse clinical, regulatory, and clerical responsibilities requiring analysis, judgement, and knowledge of clinical research. Facilitates clinical research studies with participants, staff, and sponsoring organizations.


Essential Job Functions


• Supports and models behaviors consistent with the mission and philosophy of Billings Clinic and department/service.
• Reviews and translates protocol into a specific study manual to assure adherence to protocol by all staff. Educates in-house and other Billings Clinic staff regarding protocol procedures. Prepares and submits regulatory documents to pharmaceutical companies and institutional review boards (IRBs).
• Creates and implements appropriate participant recruiting tools; screens and obtains informed consent from participants, adhering to regulatory requirements and the rights of the participant in research. Coordinates information and documentation systems and processes to meet the needs for conducting clinical research studies including screening logs, participant information lists, study specific source documents, phone logs, drug logs, and any others as needed.
• Facilitates participant education regarding the role of a research subject, and the specific requirements of the research protocol they participate in. Provides participant with appropriate teaching materials to help facilitate understanding and compliance.
• Collects data and documents in source documents as well as in case report forms. Implements and maintains regulatory documents. Prepares for and participates in monitoring visits and audits.
• Performs health assessments; prepares and dispenses medication; obtains biological samples; and performs other duties required by protocols.
• Reports adverse events per FDA, IRB, and sponsor guidelines. Notifies appropriate physician as necessary, and follows up on adverse events as required.
• Identifies needs and sets goals for own growth and development; meets all mandatory organizational and departmental requirements.
• Maintains competency in all organizational, departmental and outside agency environmental, employee or patient safety standards relevant to job performance.
• Performs other duties as assigned or needed to meet the needs of the department/organization.