Clinical Research Coordinator

University of Texas; Utah; On-site; USD 53,000 - 75,000; Full time

Job summary

The University of Texas at Austin is seeking a Clinical Research Coordinator in the Department of Surgery and Perioperative Care. You will coordinate start‑up, recruit and consent participants, and manage visits and data in compliance with ICH‑GCP and FDA/IRB requirements.

Responsibilities include regulatory maintenance, IP tracking, and collaboration with sponsors, CRAs, and clinical teams to ensure quality data and participant safety.

Qualifications

• Bachelor’s degree in health, life science, or related field.
• 3 years of clinical research coordination or closely related human-subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).
• Ability to work comfortably in a clinical environment, including the operating room.
• Adherence to established work schedules and reliable attendance.
• Master’s degree preferred; additional certifications in GCP/IRB are advantageous.

Responsibilities

• Coordinates study start‑up and feasibility, assists with budget/coverage analysis inputs and study calendars.
• Recruits, screens, and consents participants per FDA/IRB guidelines.
• Plans and conducts protocol‑specified assessments and visits with data entry into EDC/CTMS.
• Maintains regulatory binders/eTMF and submits amendments and continuing reviews.
• Ensures participant safety, monitors AEs/SAEs, and escalates medical concerns as needed.
• Performs data quality checks and supports on-site/remote monitoring and audits.

Skills

ICH-GCP & FDA/IRB guidance

EDC/CTMS proficiency

Regulatory compliance

Effective communication

Education

Bachelor’s degree in health, life science, or related field

Master’s degree preferred

Tools

Epic

EDC/CTMS

Job description

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

Key Responsibilities

• 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.

Knowledge, Skills, and Abilities

• 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 start‑up/close‑out checklists without findings on monitoring.
• Interpersonal Savvy
  • Relates well at all levels; builds constructive relationships with participants, clinicians, and sponsors.
  • Communicates complex study info in plain language to participants.
  • Navigates clinic/OR/ancillary schedules to reduce participant burden.
  • Facilitates collaborative problem‑solving with CRAs/monitors.
  • Ability to communicate clearly, professionally, and effectively with peers, patients, and patient families by phone and in person, while handling sensitive and confidential information with discretion in delicate, formal, or urgent situations.
  • Demonstrated ability to communicate effectively and professionally in written and verbal formats.
• Decision Quality
  • Makes timely, evidence‑based decisions that balance participant safety, compliance, and operational flow.
  • Determines reconsent needs after amendments using regulatory criteria.
  • Assesses AE/SAE reportability and initiates expedited reporting.
  • Applies HIPAA pathways for data access (authorization/waiver/LDS).
• Planning and Priority Setting
  • Breaks work into actionable steps; anticipates dependencies and resources.
  • Builds visit schedules aligned to windows and pre‑stages labs/shipments.
  • Sequences start‑up tasks (regulatory, training, order sets) to hit FPI dates.
  • Buffers time for monitoring, query resolution, and safety updates.
• Ethics and Values
  • Champions participant rights, data privacy, and integrity of the research record.
  • Protects PHI via minimum necessary and proper authorizations/waivers.
  • Avoids exculpatory language; ensures understandable consent.
  • Documents contemporaneously (ALCOA+) and reports deviations.
• Learning Agility
  • Rapidly learns new indications, devices, and systems; translates learning into practice.
  • Adapts to decentralized/remote monitoring processes.
  • Implements revised ICH‑GCP (E6 R3) expectations into daily work.
  • Ability to rapidly learn, adapt, and apply new information in a changing environment.

Education & Experience

• Minimum Qualifications:
  • Bachelor’s degree in health, life science, or related field; or equivalent combination of education and directly related clinical research experience.
  • 3 years of clinical research coordination or closely related human‑subjects research experience (screening/consent, visit coordination, data entry, IRB submissions).
  • Ability to work comfortably in a clinical environment, including the operating room.
  • Ability to adhere to established work schedules and maintain regular, reliable, and punctual attendance.
  • Obtaining external partners' site‑specific clinical privileges, such as immunizations, is required.
  • Relevant education and experience may be substituted as appropriate.
• Preferred Qualifications:
  • Master’s 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, IP accountability, and monitoring support.
  • Phlebotomy and ECG competencies; experience with EDC/CTMS and Epic research modules.

Licenses, Registrations or Certifications

• Required: None
• Preferred: Current GCP training consistent with ICH‑GCP E6 (R2/R3) and FDA/HHS regulations; institutional human subjects protection training. ECG competencies; experience with EDC/CTMS and Epic research modules.

Salary Range $53,464 + depending on qualifications

Working Environment / Equipment

• Standard office equipment
• Repetitive use of a keyboard

Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University‑Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.

Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Background Checks: A criminal history background check will be required for finalist(s) under consideration for this position.

Equal Opportunity Employer: The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies 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.

Pay Transparency: The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Employment Eligibility Verification: If hired, you will be required to complete the federal Employment Eligibility Verification I‑9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.

E‑Verify: The University of Texas at Austin use E‑Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E‑Verify is 854197. For more information about E‑Verify, please see the following: E‑Verify Poster (English and Spanish) [PDF] Right to Work Poster (English) [PDF] Right to Work Poster (Spanish) [PDF]

Compliance: Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act) and Clery Act. If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP‑3031. The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.

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