Clinical Research Coordinator

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

• 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 meetings, and community outreach events related to studies.
  • Trains new team members on study workflows, documentation standards, and GCP basics.
  • Supports internal audits and readiness for regulatory inspections.
  • Adheres to internal controls and reporting structure.
  • Performs other duties as required.

• Managing and Measuring Work
  • Sets clear objectives, uses metrics to monitor progress, and holds self/others accountable for results.
  • Defines visit/metric KPIs (screen‑fail rate, query cycle time) for each protocol.
  • Implements trackers (e.g., screening logs, IP logs) and reviews weekly.
  • Escalates barriers early and re‑prioritizes tasks to hit enrollment and data‑lock timelines.
• Functional/Technical Skills (Clinical Research Operations)
  • Possesses deep, hands‑on expertise in ICH‑GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.
  • Applies ICH‑GCP and FDA/IRB guidance to consent and AE reporting decisions.
  • Operates EDC/CTMS/EPIC research modules with high data accuracy.
  • Executes…