JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: Under the direction of an assigned supervisor, this position assists with activities pertaining to the SMART Trial, an opioid use disorder behavioral treatment trial. Specifically, this position focuses on clinical trial supervision, study recruitment/retention, data collection, and behavioral intervention delivery. Ensures all study staff, principal investigator, and department successfully achieve the goals of the study in a timely manner.
DUTIES AND RESPONSIBILITIES:
Oversees regulatory duties including study record keeping, data quality assurance, consent procedures, adverse event reports, and any additional requirements specified by IRB, FDA, or other authorized regulatory bodies.
Assists with training staff in data collection and informed consent procedures.
Provides ideas and suggestions for all phases of assigned project(s).
Ensures the timely and accurate entry of all required research, clinical, and administrative data.
Helps with planning, executing, and creating/maintaining records and minutes for all meetings and video/teleconferences.
Abides by research and program leadership by assisting with reports, research summaries, and appropriate contributions to patient-directed materials
Delivers scripted behavioral interventions over-the-phone and in-person to study participants as specified in the study protocol(s).
Screens potential participants for eligibility.
Administers appropriate assessments and enters data in database in real time.
Documents all adverse events, medication adjustments, and/or protocol deviations reported by study participants using protocol specific forms and procedures while utilizing good clinical judgment.
Distributes participant incentives by mail and in-person and document all transactions.
Assists in participant retention activities and serve as study participants' primary contact person after they are randomized to study intervention groups and respond to any questions concerns either directly or through referral to appropriate staff.
Attends protocol specific research meetings to troubleshoot any potential problems regarding assigned protocol(s).
Performs other related duties assigned.
Internal Number: 209947
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