• Participates in assessing feasibility of clinical research opportunities, including protocol and population assessments.
• Assists in preparation of submissions for Institutional Review Board consideration and provides oversight for all reporting obligations.
• Develops the research informed consent document in compliance with all applicable regulations.
• Responsible for conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, follow-up, and retention of eligible subjects according to protocol requirements.
• Maintains responsibility for investigational drug and device accountability.
• Monitors study finances to comply with study-specific budget.
• Direct patient care in the context of the study protocol.
• Administers and monitors investigational drugs and devices as directed by the investigator and clinician within the scope of professional license or certification.
• Administers appropriate scales or other clinical measurements as needed within the scope of professional license or certification.
• Reviews medical records of patients, interviews patients and collaborates with investigators and clinicians to assess the appropriateness of patients for clinical trial enrollment.
• Collaborates with nursing staff and research personnel to incorporate all details of research protocol forms study related patient care within the scope of professional license or certification.
• Provides education to subjects and family on specific research protocols, potential risks, benefits, and reporting of health events.
• Serves as a liaison between the principal investigator and the study sponsor for adapting a multi-center protocol to the specific local environment.
• Serves as site representative during sponsor initiated study audits.
• Serves as a liaison between the principal investigator and outside regulatory agencies.

Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.