Clinical Research Associate I

The University of Texas at Austin•Austin, UT

5d•Onsite

About The Position

The Clinical Research Associate I (CRA I) provides foundational operational support for clinical trials under close supervision. The role supports routine monitoring activities, data accuracy checks, document preparation, and visit scheduling to help ensure protocol adherence, participant safety verification, and data integrity. The CRA I supports remote and on-site monitoring visits performed by senior CRAs or project leadership and works closely with Clinical Research Coordinators, regulatory staff, data management teams, investigational pharmacy, and study leadership. The position typically reports to a Clinical Project Manager or Senior CRA. This is a grant-funded position expected to continue through August 31, 2027, and is renewable based on funding availability, work performance, and progress toward research goals. The position is scheduled for 40 hours per week at the UT Main Campus in the Department of Psychiatry at Dell Medical School.

Requirements

Bachelor's degree in life sciences, nursing, public health, or a related field; relevant education and experience may be substituted as appropriate.
Basic understanding of GCP and Human Subjects Protection.
Demonstrated ability to follow SOPs, maintain accuracy, and learn quickly.
Ability to maintain the security or integrity of critical infrastructure, where applicable under Texas Executive Order No. GA-48.
At least 1 year of clinical research support experience is listed as preferred, not required.

Nice To Haves

Bachelor's degree in life sciences, nursing, public health, or a related field with at least 1 year of clinical research support experience, such as CTA, CRC assistant, or research intern experience.
Experience with EDC/CTMS systems.
Familiarity with risk-based monitoring concepts.
GCP training (ICH E6) and institutional human subjects training upon hire.
IATA certification if assigned to handle or ship specimens.
ACRP (CCRA, ACRP-CP) or SOCRA CCRP certification; not required at hire.

Responsibilities

Assist senior CRAs with preparation for qualification, initiation, monitoring, and close-out visits; participate in remote or in-person visits in a shadowing or support capacity.
Conduct supervised source data review and basic source data verification, and draft or update visit documentation for senior review.
Perform supervised chart reviews and basic completeness, accuracy, and consistency checks; track and help resolve queries; identify missing data or discrepancies for escalation.
Collect, upload, organize, and track essential regulatory documents; conduct supervised ISF/TMF quality checks; prepare document packets for monitoring visits and audits.
Perform preliminary consent-document checks for version alignment; review AE/SAE listings and documents for completeness; verify eligibility criteria alignment during chart review and escalate uncertainties.
Assist with feasibility and site assessment documentation; prepare training materials and trackers; schedule meetings and maintain study training logs.
Update CTMS, EDC task lists, issue logs, and monitoring visit calendars; prepare status updates and communicate site needs, questions, and progress in a timely manner.
Prepare investigational product accountability forms and checklists; assist senior CRAs in reviewing pharmacy logs and storage records.
Assist with document retrieval and pre-audit file checks, and participate in CAPA action tracking managed by senior team members.
Assist with centralized data review for risk-based monitoring; participate in co-monitoring visits and retraining as assigned; support SOP updates, toolkit revisions, or CAPA documentation; coordinate minor document or data requests with vendors; adhere to internal controls and reporting structure; perform related duties as required.
Follow monitoring plans, SOPs, checklists, and approved systems; maintain accurate documentation; escalate uncertainty and potential risks to senior staff.
Use standard office equipment and perform repetitive keyboard use.