Registered Nurse - Biobehavioral Research Coordinator

Must be able to organize complex components of clinical trials, including test ordering, procedure scheduling and insurance pre-authorization for participants, if applicable. Clinical skills that may be required include, but not limited to: patient assessment for adverse events and assistance with, or completion of, study related procedures as detailed in the research protocol (ex: injections, phlebotomy, or infusions), within the applicable state scope of practice. Demonstrate a desire and ability to strictly adhere to all levels of institutional, state and federal regulations and established research protocols, and the ability to collaborate with physician investigators to ensure safe and compliant investigational treatment or intervention and follow-up.

Attend investigator meetings and coordinate pre-study site visits. Monitor enrollment goals and modify recruitment plan as needed. Ensure the completion of all screening, eligibility and enrollment procedures.

Work with pharmacy to dispense study articles and provide subject education. Clarify questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures. Review inclusion/exclusion criteria to assure subject eligibility and review with physician investigator.

Review study protocol, informed consent form and follow-up procedures with potential study subjects. Schedule subjects for follow-up visits to review diaries and questionnaires. Ensure appropriate specimen collection, batching and shipping as required.

Document and maintain all study-related procedures, processes and events. Document protocol deviations and exemptions and record accurate and timely data. Maintain accurate source documentation for all case report entries and input data for submission.

Required to use appropriate nursing assessment skills to evaluate patient condition in response to study intervention. Collect data regarding patient condition for review by the physician investigator. Prepare case report forms and source documents for sponsor review.

Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets. Communicate effectively with subjects, research team, Institutional Review Board (IRB) and sponsor representatives. Occasional local travel between sites and student supervision may be required.