Clinical Research Coordinator II, Neurological Surgery

Job Summary The CRC II will coordinate and manage a portfolio of high‑complexity, investigator‑initiated trials as well as grant and industry‑funded trials in the Department of Neurological Surgery. These include trials investigating the safety and efficacy of experimental drugs for embolization treatment of subdural hematomas, sonodynamic therapy for glioblastoma multiforme, deep brain stimulation for OCD and depression, functional restoration in paralyzed individuals using brain‑computer interface implants, and complex investigative device trials for which the FDA IDE will be held by the PIs within our department. Responsibilities Directly interact with clinical research participants, as required, for non‑clinical and clinical procedures via telephone, telehealth or in‑person. Coordinate regulatory documentation for research studies, maintaining information to comply with industry standards, university policies, FDA requirements or other hospital policies. Coordinate and schedule procedures as per research study. A non‑licensed coordinator may pend study order sets with oversight by PI. Screens, recruits, enrolls and follows subjects according to research protocol guidelines. May assist with consent processes. Maintain and coordinate data collection information required for each study, including developing CRFs or data collection tools. Assist in developing and implementing research studies, which may include writing clinical research protocols. Conduct research procedures according to the protocol with proper training and check‑offs to maintain scope of service. Assist the PI on fiscal management of the trial, including budget preparation. Monitor patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Perform research billing activities, as needed, based on department size (including linking patient calendars). Coordinate data management and collection for national (larger/more complex) research studies or multiple research studies at a given time. Serve as primary liaison/lead in preparing annual reports for federal, state, and/or local agencies on assigned studies. Prepare protocols for Institutional Review Board (IRB) submission and submit amendments and continuing review documents as required. Provide in‑service training to all study team members and communicate to involved groups. Review research study protocols to ensure feasibility requirements of the study. Assist in developing websites or other social media for marketing/recruiting based on assigned clinical research study. Enter data or assist in assembling data to enter in the assigned clinical trial management system, electronic medical record, and/or other required data entry systems. Maintain required subject documentation for each study protocol. Perform other duties as assigned. Qualifications Required Bachelor’s degree in a medical or science‑related field. At least 2 years of clinical research experience. Consideration may be given for additional years of experience or an advanced degree in lieu of education or experience, respectively. Preferred Licenses and certifications: Basic Life Support (BLS) and CPR AED may be required based on research study protocols or affiliate location requirements; ACRP or SOCRA certification is a plus. Benefits PPO medical plan, available day one at no cost for full‑time employee‑only coverage. 100% coverage for preventive healthcare—no copay. Paid Time Off, available day one. Retirement programs through the Teacher Retirement System of Texas (TRS). Paid parental leave benefit. Wellness programs. Tuition reimbursement. Public Service Loan Forgiveness (PSLF) qualified employer. EEO Statement UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, genetic information, citizenship status, or veteran status. Location 5323 Harry Hines Blvd, Dallas, TX. #J-18808-Ljbffr UT Southwestern Medical Center