Clinical Research Coordinator

Benefits

Additional Information

Job Posting Title: Clinical Research Coordinator ---- Hiring Department: Department of Surgery and Perioperative Care ---- Position Open To: All Applicants ---- 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 ---- Job Details: General Notes The Department of Surgery and Perioperative Care seeks to advance innovation from discovery to outcomes. The Department brings together clinical specialties, encouraging multidisciplinary collaboration. Specialties represented within the Department include anesthesiology, emergency medicine, general surgery, orthopedic surgery, otolaryngology, plastic surgery, and urology. The Department seeks a Clinical Research Coordinator who will work effectively with faculty Principal Investigators (PI) to ensure successful participation in key mission-aligned research studies. Read more about the Department , our research , and our culture . Work will take place in an office setting in the Health Discovery Building (HDB); some work will take place in clinical areas of the Health Transformation Building (HTB) and/or Dell Seton Medical Center at UT (DSMC-UT). This position is eligible for a hybrid Flexible Work Arrangement (FWA) (on-campus and remote work). On-campus presence will be required as determined by PI/ Manager and specific study needs. FWA arrangements are subject to manager approval and may shift due to changes in business needs. The remote location must have a reliable internet connection to support working remotely. Finalist is required to complete Ascension Seton Research Affiliate application and UT Health Worklife Screening process, part of this involves proof of and/or completion of immunizations for our affiliate's approval. Applicant must be authorized to work in the United States, without employer sponsorship, on a full-time basis for any employer. The Clinical Research Coordinator manages day‑to‑day study operations under the direction of a Principal Investigator (PI), ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance across start‑up, conduct, and close‑out activities. Typical partnerships include investigators, research nurses, pharmacists, laboratory teams, radiology, billing/compliance, and sponsor/CRO monitors; the role commonly reports to a PI, Research Manager, or Clinical Research Operations lead. ESSENTIAL JOB FUNCTIONS: Coordinates study start‑up and feasibility - Conducts pre‑study feasibility and assists with budget/coverage analysis inputs and study calendars. - Prepares start‑up packages, facilitates site‑initiation, and implements IRB‑approved protocols/SOPs. - Collaborates with pharmacy, lab, and radiology to establish workflows and order sets. Recruits, screens, and consents participants - Identifies candidates via chart review and referrals; applies inclusion/exclusion criteria. - Obtains and documents informed consent consistent with FDA guidance and IRB requirements. - Educates participants on study procedures, risks/benefits, and alternatives; coordinates pre‑screening tests. Plans and conducts study visits - Schedules and executes protocol‑specified assessments (e.g., vitals, ECGs, sample collection/processing) per competency and delegation. - Documents source data contemporaneously (ALCOA/ALCOA+), and enters data into EDC/CTMS. - Maintains investigational product (IP) accountability and coordinates shipments per sponsor SOPs. Ensures participant safety and reporting - Monitors participants for AEs/SAEs and reports per protocol, IRB, and FDA requirements. - Implements re‑consent and safety updates; escalates medical concerns to PI. - Tracks protocol deviations and executes CAPAs to prevent recurrence. Manages regulatory and ethics documentation - Maintains regulatory binders/eTMF, version control for consents, and IRB correspondence. - Submits amendments, safety letters (e.g., IND safety reports), and continuing reviews. - Applies ICH‑GCP (E6) and U.S. regulations. Oversees data quality and monitoring - Performs source data review/verification readiness; responds to sponsor/CRO queries. - Supports onsite/remote monitoring and audits; implements quality checks. - Maintains data confidentiality per HIPAA and institutional policies. Coordinates site operations and stakeholder communication - Liaises with sponsors/CRAs, clinics, and ancillary departments; prepares status updates. - Supports study budgets and research billing workflows with appropriate routing. Conducts study close‑out - Reconciles data, IP, and essential documents; archives records per retention requirements. - Facilitates final monitoring/close‑out visits and records lessons learned. Other Job Duties may apply as assigned Marginal or Periodic Functions: - Assists with protocol development, informed consent drafting, and recruitment materials. - Participates in investigator