Lead Clinical Research Coordinator, Psychiatry Molecular Imaging

Overview Lead Clinical Research Coordinator, Psychiatry Molecular Imaging - (904445) Lead Clinical Research Coordinator, Psychiatry Molecular Imaging - (904445) Job Summary The Molecular Imaging in Psychiatry Program at UT Southwestern seeks a highly organized, detail-oriented Clinical Research Coordinator I to support PET and MRI studies investigating brain chemistry in psychiatric and neurologic disorders. This role involves coordinating participant visits, managing imaging and clinical data, maintaining regulatory compliance, and working closely with interdisciplinary teams across Psychiatry, Radiology, and the Advanced Imaging Research Center. Ideal candidates will have strong communication skills, a collaborative mindset, and an interest in molecular imaging or translational neuroscience. Benefits UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: PPO medical plan, available day one at no cost for full-time employee-only coverage 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 Education and Experience Education Bachelor’s Degree in medical or science related field Experience 4 years of clinical research experience with Bachelor’s Degree. Prior experience in the UT Southwestern clinical research mentoring program is highly desirable and may count as additional experience. May consider additional years of experience or advanced degree in lieu of education or experience. Preferred Experience Experience supporting PET or MRI research studies, particularly involving investigational radiotracers or pharmacokinetic modeling. Familiarity with Institutional Review Board (IRB) and FDA Investigational New Drug (IND) regulatory processes. Prior exposure with arterial or venous blood sampling in human studies. Working knowledge of REDCap or equivalent databases and familiarity with imaging data management systems or NIH Data Archive submissions. Licenses and Certifications (BLS) Basic Life Support may be required based on study protocols or location requirements. (CPRAED) CPR AED may be required based on study protocols or location requirements. ACRP or SOCRA certification a plus. Job Duties Recruit, screen, consent, and schedule research participants according to IRB-approved protocols. Coordinate complex PET/MR imaging visits and blood sampling procedures in collaboration with chemistry, imaging, and clinical teams. Provide compassionate participant support, including assistance for individuals with cognitive impairment or psychosis, ensuring safety and comfort during all study procedures. Conduct accurate data entry, de-identification, and quality control for imaging and clinical data. Collaborate with imaging physicists to review PET/MR data for completeness and quality assurance. Prepare datasets for upload to the NIH Data Archive and maintain appropriate data documentation. Track and document biospecimen processing, including arterial plasma samples and radiotracer metabolism assays. Maintain regulatory documentation for IRB, FDA (IND), and institutional audits; assist with submissions, renewals, and amendments. Ensure compliance with Good Clinical Practice (GCP), HIPAA, and radiation safety requirements. Serve as liaison between psychiatry investigators, PET/MR technologists, radiochemistry staff, radiology fellows, physicists, and biologists to coordinate scheduling and communication. Contribute to development of standard operating procedures (SOPs) for imaging workflows, data handling, and participant logistics. Assist in training and onboarding future coordinators as the research team expands. Maintains required subject documentation for each study protocol. Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person. Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies. Coordinates and schedules 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 (non-clinical and clinical procedures). May also assist with the consent processes. Maintains and coordinates data collection information required for each study that may also include developing CRFs (case report forms) or data collection tools. Assists in developing and implementing research studies, may include writing clinical research protocols. Conducts research procedures according to the protocol with proper training and check-offs to maintain scope of service. May provide supervision to other members of the research team as necessary. May perform research billing activities, as needed, based on size of department (including linking patient calendars). Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including HRPP, FDA, Sponsored Programs, and affiliated hospitals. Coordinates data management and collection for national (larger/more complex) research studies. Serves as lead in preparing annual reports for federal, state, and local agencies on assigned studies. Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents. Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies. Provides in-service training to all study team members and communicates to involved groups. Reviews research study protocols to ensure feasibility requirements of the study. Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study. Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems. Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records; or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. Security and EEO Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. EEO 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, gender expression, age, disability, genetic information, citizenship status, or veteran status. #J-18808-Ljbffr