Clinical Research Coordinator

University of Texas at Austin•Austin, TX

14d•$53,464•Onsite

About The Position

The Clinical Research Coordinator manages day-to-day study operations under the direction of a Principal Investigator, supporting bipolar disorder research in the Department of Psychiatry and Behavioral Sciences at Dell Medical School. The role ensures protocol fidelity, participant safety, data integrity, and regulatory compliance throughout study start-up, conduct, and close-out. This grant-funded position is expected to continue through December 31, 2027, and may be renewed depending on funding availability, work performance, and progress toward research goals. The position is scheduled for 40 hours per week and may require flexible hours, including weekends and after normal business hours, to meet deadlines. The coordinator works with investigators, research nurses, pharmacists, laboratory and radiology teams, billing and compliance staff, sponsors, and contract research organization monitors. Duties include assessing feasibility; preparing study start-up materials; recruiting, screening, and consenting participants; coordinating study visits and assessments; maintaining investigational product accountability; monitoring participant safety; managing regulatory and ethics documentation; supporting data quality and monitoring; coordinating site operations and stakeholder communications; and completing study close-out activities. The role also supports protocol development, recruitment materials, investigator meetings, community outreach, staff training, internal audits, and inspection readiness. The role requires a bachelor's degree in a relevant field and at least three years of clinical research coordination or closely related human-subjects research experience, along with phlebotomy and ECG competencies. Relevant education and experience may be substituted as appropriate. A master's degree and experience with interventional trials and specified research systems and procedures are preferred.

Requirements

Bachelor's degree in health, psychology, neuroscience, life science, or a related field; relevant education and experience may be substituted as appropriate.
At least 3 years of experience in clinical research coordination or closely related human-subjects research, including screening/consent, visit coordination, data entry, and IRB submissions; relevant education and experience may be substituted as appropriate.
Phlebotomy and ECG competencies.
Willingness to work weekends and after normal business hours when needed.
Excellent time-management and organizational skills and attention to detail.
Hands-on knowledge of ICH-GCP, IRB/HIPAA, EDC/CTMS, and protocol conduct.
Ability to work professionally and tactfully with interdisciplinary teams, participants, clinicians, fellows, research associates, and sponsors, including participants living with severe mental illness.
Ability to make timely, evidence-based decisions that balance participant safety, compliance, and operational needs.
Ability to maintain security or integrity of critical infrastructure, as required by Texas Executive Order No. GA-48 for applicable roles.

Nice To Haves

Master's degree in nursing, allied health, psychology, neuroscience, public health, biology, pharmacology, or a related field.
At least 1 year of 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.
SOCRA CCRP certification.
BLS/CPR certification 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 study start-up packages, facilitate site initiation, and implement IRB-approved protocols and standard operating procedures.
Coordinate with pharmacy, laboratory, and radiology teams to establish study workflows and order sets.
Identify potential participants through chart review and referrals and assess them against inclusion and exclusion criteria.
Obtain and document informed consent in accordance with FDA guidance and IRB requirements; explain procedures, risks, benefits, and alternatives to participants.
Coordinate pre-screening tests and schedule and conduct protocol-specified study visits and assessments, including vitals, ECGs, sample collection and processing, neuroimaging, and neurocognitive assessments, as authorized by competency and delegation.
Document source data contemporaneously in accordance with ALCOA/ALCOA+ and enter data into EDC/CTMS systems.
Maintain investigational product accountability and coordinate shipments according to sponsor procedures.
Monitor participants for adverse events and serious adverse events and report them according to protocol, IRB, and FDA requirements.
Implement re-consent and safety updates, escalate medical concerns to the Principal Investigator, track protocol deviations, and execute corrective and preventive actions.
Maintain regulatory binders and eTMF, consent version control, and IRB correspondence; submit amendments, safety letters, and continuing reviews.
Apply ICH-GCP and U.S. regulatory requirements.
Prepare for source-data review and verification; respond promptly to sponsor and CRO queries; support monitoring and audits and implement quality checks.
Maintain data confidentiality in accordance with HIPAA and institutional policies.
Liaise with sponsors, CRAs, clinics, and ancillary departments; prepare study status updates; and support study budgets and research billing workflows.
Reconcile study data, investigational product, and essential documents; archive records according to retention requirements; and facilitate final monitoring and close-out visits.
Assist with protocol development, informed consent drafting, and recruitment materials.
Participate in investigator meetings and study-related community outreach events.
Train new team members on study workflows, documentation standards, and GCP basics.
Support internal audits and readiness for regulatory inspections; adhere to internal controls and reporting structures; and perform related duties as required.