Clinical Research Coordinator

Clinical Research Coordinator Department: Surgery and Perioperative Care – University of Texas at Austin Position Details Location: UT Main Campus (Health Discovery Building) with hybrid work arrangement; Some activities may be performed in clinical areas of the Health Transformation Building or Dell Seton Medical Center Weekly Hours: 40. Full‑time, Exempt from FLSA Start Date: Immediately Duration: Until August 31, 2028 Essential Job Functions Coordinate study start‑up and feasibility: conduct pre‑study feasibility, assist with budget and coverage analysis, prepare start‑up packages, facilitate site initiation, and implement IRB‑approved protocols and SOPs. Recruit, screen, and obtain informed consent for participants: identify candidates, apply inclusion/exclusion criteria, obtain and document informed consent and educate participants on study procedures and risks. Plan and conduct study visits: schedule and execute protocol‑specified assessments, document source data contemporaneously, enter data into EDC/CTMS, manage investigational product accountability, and coordinate shipments per sponsor SOPs. Ensure participant safety and reporting: monitor participants for AEs/SAEs, report per protocol, IRB, and FDA requirements, implement re‑consent and safety updates, and escalates medical concerns to the PI. Manage regulatory and ethics documentation: maintain regulatory binders and eTMF, version control consents, handle IRB correspondence, submit amendments and safety letters, and apply ICH‑GCP (E6) and U.S. regulations. Oversee data quality and monitoring: perform source data review, respond to sponsor/CRO queries, support onsite and remote monitoring and audits, and maintain data confidentiality under HIPAA. Coordinate site operations and stakeholder communication: liaise with sponsors, CRAs, clinics, and ancillary departments, prepare status updates, support study budgets and billing workflows. Conduct study close‑out: reconcile data and investigational product, archive records per retention requirements, facilitate final monitoring/close‑out visits, and document lessons learned. Marginal or Periodic Functions Assist with protocol development, informed consent drafting, and recruitment materials. Participate in investigator meetings and community outreach events related to studies. Train new team members on study workflows, documentation standards, and GCP basics. Support internal audits and readiness for regulatory inspections. Adhere to internal controls and reporting structure. Perform other duties as required. Knowledge, Skills, and Abilities Managing and Measuring Work : set objectives, use metrics to monitor progress, define KPIs such as screen‑fail rate and query cycle time, implement trackers, and escalates barriers early. Functional/Technical Skills : deep expertise in ICH‑GCP, IRB/HIPAA, EDC/CTMS, Epic research modules; apply FDA/IRB guidance to consent and AE reporting; execute start‑up and close‑out checklists without findings. Interpersonal Savvy : build constructive relationships with participants, clinicians, and sponsors; communicate complex study information in plain language; navigate schedules to reduce participant burden; facilitate collaborative problem‑solving with CRAs and monitors. Decision Quality : make timely, evidence‑based decisions that balance participant safety, compliance, and operational flow; determine re‑consent needs after amendments; assess AE/SAE reportability and initiate expedited reporting; apply HIPAA pathways for data access. Planning and Priority Setting : break work into actionable steps, anticipate dependencies and resources, build visit schedules aligned to windows, sequence start‑up tasks, and buffer time for monitoring and safety updates. Ethics and Values : champion participant rights, uphold data privacy, ensure transparent consent, and document contemporaneously with ALCOA+ while reporting deviations. Learning Agility : rapidly learn new indications, devices, and systems; adapt to decentralized and remote monitoring; implement revised ICH‑GCP expectations into daily work. Education & Experience Minimum: Bachelor’s degree in health, life science, or related field; or equivalent combination of education and directly related clinical research experience. Three (3) years of clinical research coordination or closely related human‑subjects research experience in screening, consent, visit coordination, data entry, or IRB submissions. Ability to work comfortably in a clinical environment, including the operating room. Must obtain site‑specific clinical privileges (e.g., immunizations). Preferred Qualifications Master’s degree in Nursing, Allied Health, Public Health, Biology, Pharmacology, or related field. 1‑2 years coordinating interventional trials (oncology, cardiology, neurology, or surgical), including specimen handling, investigational product accountability, and monitoring support. Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules. Licenses, Registrations, and Certifications Preferred: Current GCP training consistent with ICH‑GCP E6 (R2/R3) and FDA/HHS regulations; institutional human subjects protection training, ECG competencies, and experience with EDC/CTMS and Epic modules. Salary $53,464 plus adjustments based on qualifications. Working Environment Standard office equipment; repetitive keyboard use. Background Check Criminal history background check required for finalists. Equal Opportunity Employer University of Texas at Austin is an equal opportunity/affirmative action employer and complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs, and activities. #J-18808-Ljbffr Myana