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. Coordinate’s 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.

Knowledge, Skills, and Abilities

• Billings Clinic policy and procedures, both organizational and departmental

• Billings Clinic Corporate Compliance Program

• Billings Clinic Code of Business Conduct

• Personal computers and printers, hardware, and software

• HIPAA and confidentiality requirements

• Patient’s rights as a research participant and standards of care in clinical research studies

• Clinical research protocols

• Food and Drug Administration (FDA), Code of Federal Regulations (CFR) and the guidelines for the International Conference on Harmonization (ICH)

• General regulatory submissions to Institutional Review Boards (IRBs)

• Nursing theory and practice to assess, evaluate, and provide quality patient care

• Infection control and safety practices and procedures

• Joint Commission and OSHA safety requirements

• Professional interpersonal communication skills

•  Advanced nursing assessments and procedures (i.e., EKGs, conscious sedation)

• Venipuncture and intravenous medication administration

• BLS CPR certification

• Preparing and maintaining records, writing reports, and responding to correspondence

• Learns quickly and maintains proficiency and knowledge within the flexibility of a rapidly changing environment

• Incorporate population specific needs into all aspects of communication and patient care; scope of services provided will encompass age groups ranging from infant through geriatric

• Communicate clearly and effectively, both verbal and written

• Establish and maintain collaborative relationships

• Work independently and problem solve appropriately

• Organize and prioritize multiple tasks

• Manage multiple tasks and deadlines

• Work with people from diverse professional and philosophical backgrounds

• Aggressively fulfill goals and objectives