Clinical Research Coordinator

The University of Texas at Austin•Austin, TX

13d

About The Position

The Clinical Research Coordinator manages day-to-day study operations under the direction of a Principal Investigator, ensuring protocol fidelity, participant safety, data integrity, and regulatory compliance across study start-up, conduct, and close-out. The position is in the Department of Psychiatry and Behavioral Sciences and supports bipolar disorder research. It is grant-funded and expected to continue through December 31, 2027; renewal depends on funding availability, performance, and progress toward research goals. The role works with investigators, research nurses, pharmacists, laboratory teams, radiology, billing and compliance staff, and sponsor or CRO monitors. It commonly reports to a PI, Research Manager, or equivalent; the posting does not specify the direct reporting role for this position. The coordinator conducts feasibility and start-up activities; recruits, screens, and consents participants; plans and conducts study visits; monitors participant safety; maintains regulatory and ethics documentation; supports data quality and monitoring; coordinates site operations and stakeholder communication; and completes study close-out. The role also may assist with protocol development, consent and recruitment materials, investigator meetings, community outreach, staff training, internal audits, and regulatory inspection readiness. The position is based in Austin, Texas, with 40 scheduled hours per week. Flexible work hours, including weekends and after normal business hours, may be needed to meet deadlines. The work environment includes standard office equipment, repetitive keyboard use, and possible exposure to biohazards.

Requirements

Bachelor's degree in health, psychology, neuroscience, life science, or a related field, with at least 3 years of clinical research coordination or closely related human-subjects research experience; relevant education and experience may be substituted as appropriate.
Experience in human-subjects research activities such as screening and consent, visit coordination, data entry, and IRB submissions.
Phlebotomy and ECG competencies.
Excellent time-management and organizational skills, with strong attention to detail.
Hands-on expertise in ICH-GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.
Ability to operate EDC/CTMS and EPIC research modules accurately.
Ability to work professionally and tactfully with an interdisciplinary team and interact comfortably with participants living with severe mental illness.
Willingness to work on weekends and after normal business hours when needed to meet deadlines.
Ability to maintain the security or integrity of critical infrastructure, as applicable under Texas Executive Order No. GA-48.
No licenses, registrations, or certifications are required.

Nice To Haves

Master's degree in nursing, allied health, psychology, neuroscience, public health, biology, pharmacology, or a related field, with at least 1 year of experience coordinating interventional trials.
Experience coordinating interventional trials in oncology, psychiatry, cardiology, neurology, or surgery, including specimen handling, investigational product accountability, and monitoring support.
Experience with EDC/CTMS and Epic research modules.
Experience with REDCap data entry or management.
Experience obtaining neuroimaging measures such as MRI or EEG.
Experience preparing peer-reviewed manuscripts or presenting at research conferences.
Experience administering neurocognitive assessments.
Current GCP training consistent with ICH-GCP E6 (R2/R3) and FDA/HHS regulations, and institutional human-subjects protection training.
CITI Human Subjects Research training.
ACRP CCRC certification; eligibility typically requires approximately 3,000 hours of verifiable clinical research experience.
SOCRA CCRP certification; eligibility may be met through experience and education pathways.
BLS/CPR if required by protocol or affiliate location.
Phlebotomist certification.

Responsibilities

Conduct pre-study feasibility and assist with budget and coverage analysis inputs and study calendars.
Prepare start-up packages, facilitate site initiation, implement IRB-approved protocols and SOPs, and coordinate workflows and order sets with pharmacy, laboratory, and radiology teams.
Identify potential participants through chart review and referrals, apply inclusion and exclusion criteria, obtain and document informed consent, educate participants, and coordinate pre-screening tests.
Schedule and conduct protocol-specified study visits and assessments, including vitals, ECGs, sample collection and processing, neuroimaging, and neurocognitive assessments as delegated and within competency.
Document source data contemporaneously and enter data into EDC/CTMS systems.
Maintain investigational product accountability and coordinate shipments according to sponsor SOPs.
Monitor participants for adverse events and serious adverse events; report as required; implement re-consent and safety updates; and escalate medical concerns to the PI.
Track protocol deviations and implement corrective and preventive actions to avoid recurrence.
Maintain regulatory binders or eTMF, consent version control, and IRB correspondence; submit amendments, safety letters, and continuing reviews; and apply ICH-GCP and U.S. regulations.
Prepare for source data review and verification, respond to sponsor and CRO queries, support monitoring and audits, implement quality checks, and maintain data confidentiality.
Coordinate with sponsors, CRAs, clinics, and ancillary departments; prepare status updates; and support study budgets and research billing workflows.
Reconcile data, investigational product, and essential documents at close-out; archive records according to retention requirements; facilitate final monitoring and close-out visits; and record lessons learned.
Assist with protocol development, informed consent drafting, and recruitment materials; participate in investigator meetings and study-related community outreach.
Train new team members on study workflows, documentation standards, and GCP basics; support internal audits and regulatory inspection readiness; adhere to internal controls and reporting structure; and perform related duties as required.
Set objectives and monitor study metrics, maintain and review trackers, escalate barriers, and reprioritize tasks to meet enrollment and data-lock timelines.
Apply regulatory and ethical requirements to consent, adverse event reporting, participant rights, privacy, and research documentation.
Plan visit schedules, anticipate dependencies and resources, and sequence study start-up tasks to meet milestones.
Complete role-based training, adapt to remote monitoring processes, and apply revised ICH-GCP expectations in daily work.