Job Description

Clinical Research Coordinator Department of Surgery and Perioperative Care Weekly Scheduled Hours: 40 FLSA Status: Exempt from FLSA Earliest Start Date: Immediately Position Duration: Expected to continue until Aug 31, 2028 Location: UT MAIN CAMPUS – office in the Health Discovery Building; occasional clinical work in Health Transformation Building and/or Dell Seton Medical Center at UT. Hybrid Flexible Work Arrangement available with on-campus presence required as directed by PI/Manager. Responsibilities Study start‑up and feasibility – Conduct pre‑study feasibility, budget/coverage analysis, prepare start‑up packages, facilitate site initiation, implement IRB‑approved protocols/SOPs, collaborate with pharmacy, lab, radiology to establish workflows and order sets. Recruitment, screening, and consent – Identify candidates via chart review and referrals, apply inclusion/exclusion criteria, obtain and document informed consent, educate participants, coordinate pre‑screening tests. Study visit planning and execution – Schedule and conduct protocol‑specified assessments, document source data (ALCOA/ALCOA+), enter data into EDC/CTMS, maintain IP accountability and coordinate sponsor shipments. Participant safety and reporting – Monitor for AEs/SAEs, report per protocol/IRB/FDA requirements, implement re‑consent and safety updates, track protocol deviations, execute CAPAs. Regulatory and ethics documentation – Manage regulatory binders/eTMF, maintain consents and IRB correspondence, submit amendments and safety letters, apply ICH‑GCP and U.S. regulations. Data quality and monitoring – Perform source data review, respond to sponsor/CRO queries, support onsite/remote monitoring and audits, maintain data confidentiality (HIPAA). Site operations and stakeholder communication – Liaise with sponsors, CRAs, clinics, and ancillary departments, prepare status updates, support budgets and billing workflows. Study close‑out – Reconcile data, IP, essential documents; archive records; facilitate final monitoring visits and document lessons learned. Additional duties – Assist with protocol development, consent drafting, recruitment materials; participate in investigator meetings and community outreach; train new team members; support audits and inspections. Minimum Qualifications Bachelor’s degree in health, life science, or related field, or equivalent education and clinical research experience. Three years of clinical research coordination or closely related human‑subjects research experience (screening/consent, visit coordination, data entry, IRB submissions). Comfortable working in a clinical environment, including operating rooms. Authorization to work in the United States without employer sponsorship. 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) with specimen handling, IP accountability, and monitoring support. Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules. Current GCP training (ICH‑GCP E6 R2/R3) and FDA/HHS regulations. Salary $53,464 + depending on qualifications. Working Environment Standard office equipment. Repetitive keyboard use. Required Materials Resume/CV. Three work references (at least one from a supervisor). Letter of interest. Equal Opportunity Statement The University of Texas at Austin is an equal opportunity/affirmative action employer. We comply with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and 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, and admissions. #J-18808-Ljbffr

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