Clinical Research Associate I

Job Posting Title:

Clinical Research Associate I ----

Hiring Department:

Department of Psychiatry ----

Position Open To:

All Applicants ----

Weekly Scheduled Hours:

40 ----

FLSA Status:

Exempt from FLSA ----

Earliest Start Date:

Immediately ----

Position Duration:

Expected to Continue Until Aug 31, 2027 ----

Location:

AUSTIN, TX ----

Job Details:

General Notes

Dell Medical School is seeking a Clinical Research Associate I. This is a grant funded position with an end date of 8/31/2027 that is renewable for another year based upon work performance and progress toward research goals.

Purpose

The Clinical Research Associate I (CRA I) provides foundational operational support for clinical trials by assisting with routine monitoring activities, data accuracy checks, document preparation, and visit scheduling under close supervision. This entry-level role helps ensure protocol adherence, participant safety verification, and data integrity by supporting site monitoring visits (remote and on-site) performed by senior CRAs or project leadership. Tasks include preparing visit materials, performing supervised chart reviews, assisting with source data verification, updating trackers, and supporting essential document collection. The CRA I typically reports to a Clinical Project Manager or Senior CRA and works closely with Clinical Research Coordinators, regulatory staff, data management teams, investigational pharmacy, and study leadership.

Responsibilities

• •Supports Site Monitoring Activities
• •Assists senior CRAs with preparation for qualification, initiation, monitoring, and close‑out visits.
• •Participates in remote/in‑person visits in a shadowing or support capacity.
• •Conducts supervised source data review (SDR) and basic source data verification (SDV), prioritizing accuracy.
• •Drafts or updates visit documentation (e.g., follow-up notes) for senior review.

• •Assists with Data Quality & Query Support
• •Conducts chart reviews and basic checks for completeness, accuracy, and consistency under supervision.
• •Tracks and helps resolve queries with site staff per guidance from senior CRAs or data management.
• •Reviews essential data listings to identify missing data or discrepancies for escalation.

• •Supports Essential Document Management (TMF/ISF)
• •Assists in collecting, uploading, organizing, and tracking essential regulatory documents.
• •Conducts supervised ISF/TMF quality checks for version control and completeness.
• •Prepares document packets for monitoring visits and audits for senior review.

• •Aids in Participant Safety & Compliance Verification
• •Performs preliminary checks of consent documentation for version alignment under oversight
• •Reviews AE/SAE listings and documents for completeness and flags issues to senior CRAs.
• •Confirms eligibility criteria alignment during chart review, escalating uncertainties

• •Contributes to Study Start-up & Training Activities
• •Assists with feasibility and site assessment documentation.
• •Prepares training materials and trackers for protocol, GCP, and site-level instructions.
• •Schedules meetings and maintains study training logs.

• •Maintains Study Trackers, Systems & Communication
• •Updates CTMS, EDC task lists, issue logs, and monitoring visit calendars.
• •Prepares routine status updates for senior CRAs or PMs.
• •Communicates site needs, questions, and status updates in a timely manner.

• •Supports Investigational Product (IP) Documentation
• •Prepares IP accountability forms and checklists for monitoring visits.
• •Assists senior CRAs in reviewing pharmacy logs and storage records.

• •Supports Audit & Inspection Readiness
• •Assists with document retrieval and basic pre‑audit file checks.
• •Participates in CAPA action tracking managed by senior team members.

Other duties as identified by department.

MARGINAL OR PERIODIC FUNCTIONS:

• •Assists with centralized data review activities for risk‑based monitoring.
• •Participates in co‑monitoring visits and retraining activities as assigned.
• •Provides support for SOP updates, toolkit revisions, or CAPA documentation as directed.
• •Coordinates with vendors (IVRS/IWRS, central labs, eCOA) on minor document or data requests.
• •Adheres to internal controls and reporting structure.
• •Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIESAttention to Detail

• •Produces accurate work; catches errors early; maintains documentation precision.
• •Detects data/document inconsistencies during supervised SDR/SDV.
• •Ensures version control when preparing essential documents.
• •Carefully follows checklists and monitoring task guides.

• •Learning Agility
• •Learns quickly; open to feedback; applies new knowledge rapidly.
• •Incorporates GCP and SOP feedback into work product.
• •Adapts to evolving monitoring tools (EDC, CTMS).
• •Asks clarifying questions early to avoid quality issues.

• •Planning & Organizing
• •Plans tasks effectively; structures work; anticipates workload steps.
• •Prepares monitoring visit files ahead of deadlines.
• •Maintains up‑to‑date trackers for action items and study progress.
• •Prioritizes high‑risk data checks when instructed.

• •Problem Solving
• •Uses structured approaches to understand and escalate issues.
• •Identifies root causes behind repeated documentation errors.
• •Distinguishes urgent vs. non‑urgent data issues.
• •Brings potential risks to senior staff promptly.

• •Following Instructions / SOP Adherence
• •Strictly adheres to processes; avoids unauthorized deviations.
• •Follows monitoring plans and SOPs exactly as written.
• •Documents tasks only within approved systems.
• •Escalates uncertainty instead of making independent decisions.

• •Interpersonal Savvy
• •Works effectively with site teams, CRAs, and study staff.
• •Communicates respectfully with CRCs and PI staff.
• •Receives feedback professionally.
• •Adapts communication style to various stakeholders.

• •Written Communication
• •Produces clear, concise documentation aligned with GCP expectations.
• •Drafts clear visit notes and status updates.
• •Writes concise query explanations.
• •Ensures accuracy before submitting documentation for review.

Required Qualifications

• •EDUCATION & EXPERIENCEMINIMUM QUALIFICATIONS: Requires a Bachelor's Degree in life sciences, nursing, public health or a related field.
• •Basic understanding of GCP/Human Subjects Protection
• •Demonstrated ability to follow SOPs, maintain accuracy, and learn quickly.
• •Relevant education and experience may be substituted as appropriate.

PREFERRED QUALIFICATIONS:

Bachelor's Degree in life sciences, nursing, public health or a related field with at least 1 year of experience in clinical research support (CTA, CRC assistant, research intern).

· Experience with EDC/CTMS systems

· Familiarity with risk‑based monitoring concepts.

LICENSES, REGISTRATIONS OR CERTIFICATIONS

REQUIRED:

None

PREFERRED:

• •GCP training (ICH E6) and institutional human subjects training upon hire.
• •IATA certification if handling/shipping specimens (applies only if assigned).
• •ACRP (CCRA, ACRP‑CP) or SOCRA CCRP® certification (not required at hire).

Salary Range

$40,000 + depending on qualifications

Working Conditions

Standard office equipment

Repetitive use of a keyboard

Required Materials

• •Resume/CV
• •3 work references with their contact information; at least one reference should be from a supervisor
• •Letter of interest

Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make change