Clinical Research Coordinator II

Overview Clinical Research Coordinator II – (959089). Works under the direction of an Investigator with limited supervision to coordinate research projects. This position primarily performs patient/participant coordination, may conduct data management for smaller departments as needed, and collects and ensures quality control of clinical or basic research data to support multiple and/or complex studies. Responsibilities Directly interacts with clinical research participants (non-clinical and clinical procedures) via telephone, telehealth, or in person. Coordinate regulatory documentation for research studies to comply with industry standards, University policies, FDA requirements, or other hospital policies. Coordinate and schedule procedures per research study; a non-licensed coordinator may pend study order sets with PI oversight. Screen, recruit, enroll, and follow subjects according to protocol guidelines; assist with consent processes as needed. Maintain and coordinate data collection, including developing CRFs or data collection tools. Assist in developing and implementing research studies, including 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 with fiscal management of the trial, including budget preparation. Monitor patient safety by reviewing records and ensuring proper reporting per protocol and HRPP standards. May perform research billing activities as needed, including linking patient calendars. Coordinate data management and collection for national or larger/more complex studies, or multiple studies at a time. Serve as primary liaison/lead in preparing annual reports for federal, state, or local agencies on assigned studies. Prepare protocols for Institutional Review Board (IRB) submission; submit amendments and continuing review documents as appropriate. Provide in-service training to study team members and communicate with involved groups. Review study protocols to ensure feasibility requirements are met. Assist in developing websites or other social media for marketing/recruiting based on assigned clinical research study. Enter data or assist in assembling data for entry in the assigned clinical trial management system, electronic medical record, or other data entry systems. Maintain required subject documentation for each study protocol. Perform duties that may include direct interaction with patients or human-subjects, and/or handling patient records. Performs other duties as assigned. Qualifications Required Education : Bachelor’s Degree in a medical or science-related field Experience : 2 years clinical research experience. Additional years of experience or an advanced degree may be considered in lieu of education or experience. Preferred Licenses and Certifications : CPR/BLS may be required based on study protocols or affiliate location requirements. CPR AED may be required. ACRP or SOCRA certification is a plus. Benefits PPO medical plan, available day one 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 Learn more about these and other UT Southwestern employee benefits Security and Equal Employment Opportunity This position is security-sensitive and subject to state requirements. UT Southwestern Medical Center is committed to equal opportunity and prohibits unlawful discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, genetic information, citizenship status, or veteran status. UT Southwestern also prohibits harassment on the basis of sexual orientation, gender identity, or gender expression. #J-18808-Ljbffr The University of Texas Southwestern Medical Center