Clinical Research Associate I

Job Posting Title:

Clinical Research Associate I

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Hiring Department:

Department of Psychiatry

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Position Open To:

All Applicants

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Weekly Scheduled Hours:

40

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FLSA Status:

Exempt

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Earliest Start Date:

Immediately

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Position Duration:

Expected to Continue Until Sep 01, 2027

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Location:

AUSTIN, TX

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Job Details:

General Notes

This is a grant-funded position with an end date of September 1, 2027, renewable based upon availability of funding, work performance, and progress toward research goals.

Purpose

The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.

The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI). This role may coordinate the data collection and operations of multiple concurrent clinical research studies under the guidelines of research protocols, The University of Texas at Austin, and regulatory agency policies.

A successful candidate will possess strong attention to detail; excellent interpersonal, verbal, and written communication skills; the ability to coordinate with subjects, team members, other departments, and external institutions; the ability to multitask in a fast-paced environment while working with a diverse subject population; and the ability to prioritize and complete multiple projects within established deadlines.

Responsibilities

Site Management & Study Execution

• Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.

• Ensure compliance with study protocols and regulatory requirements.

• Manage site performance and resolve issues.

• Administer questionnaires, collect medical history, and perform study procedures.

• Maintain rapport with participants to support retention and address concerns.

• Obtain informed consent and ensure participant safety throughout protocol procedures.

• Coordinate with affiliated departments and external collaborators.

Data Collection & Management

• Collect and verify data from clinical sites.

• Ensure accurate and timely data entry into electronic data capture systems (e.g., REDCap).

• Review and resolve data queries.

• Assist with manuscript and grant preparation, including opportunities for authorship.

• Maintain and update study databases and data collection forms.

Regulatory Compliance & Oversight

• Ensure adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

• Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.

• Prepare and maintain regulatory documents.

• Coordinate with ethics committees to safeguard participant rights.

• Participate in internal and external audits and protocol reviews.

Participant Recruitment & Retention

• Evaluate medical records and perform screenings to identify eligible study participants.

• Assist in screening and enrolling study participants.

• Maintain communication with participants to support retention.

• Address participant concerns and inquiries.

Reporting & Documentation

• Prepare study reports and documentation.

• Maintain accurate records of study activities.

• Assist in the preparation of manuscripts and publications.

Marginal or Periodic Functions

• Conduct literature reviews to support study design and protocol development.

• Assist in training new site staff and research team members.

• Participate in internal and external audits.

• Support development of study protocols and case report forms.

• Attend conferences and workshops to stay updated on industry trends.

• Adhere to internal controls and reporting structure.

• Perform related duties as required.

Knowledge, Skills, an