Clinical Research Associate I
Description
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 from FLSA
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Earliest Start Date
Immediately
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Position Duration
Expected to Continue Until Aug 31, 2027
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Location
AUSTIN, TX
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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
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- 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
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- 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.
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LICENSES, REGISTRATIONS OR CERTIFICATIONS
REQUIRED
- None
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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
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Required Materials
- Resume/CV
- 3 work references with their contact information; at least one reference should be from a supervisor
- Letter of interest