Clinical Research Coordinator

University of Texas at Austin

13d•Hybrid

About The Position

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. 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.

Requirements

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.
Managing and Measuring Work · Sets clear objectives, uses metrics to monitor progress, and holds self/others accountable for results.
Functional/Technical Skills (Clinical Research Operations) · Possesses deep, hands‑on expertise in ICH‑GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.
Interpersonal Savvy Relates well at all levels; builds constructive relationships with participants, clinicians, and sponsors.
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.
Planning and Priority Setting Breaks work into actionable steps; anticipates dependencies and resources.
Ethics and Values Champions participant rights, data privacy, and integrity of the research record.
Learning Agility Rapidly learns new indications, devices, and systems; translates learning into practice.

Nice To Haves

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.
Current GCP training consistent with ICH‑GCP E6 (R2/R3) and FDA/HHS regulations; institutional human subjects protection training.

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.
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.