Clinical Research Coordinator, Freeman Lab

University of Texas at Austin•Austin, TX

About The Position

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. This is a temporary position with an end date of one year from the start date, but may be renewable based upon availability of funding, work performance, and progress toward research goals.

Requirements

Bachelor’s degree in a 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).

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.
ACRP CCRC® (Certified Clinical Research Coordinator) – eligibility typically requires ~3,000 hours of verifiable clinical research experience.
SOCRA CCRP® – eligibility via experience/education pathways (e.g., two years full‑time CRP experience).
BLS/CPR if required by protocol or affiliate location.

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 tumor boards, 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 related duties as required.