Job Description

Clinical Research Associate I

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 include assisting with centralized data review activities for risk-based monitoring, participating in co-monitoring visits and retraining activities as assigned, providing support for SOP updates, toolkit revisions, or CAPA documentation as directed, coordinating with vendors on minor document or data requests, adhering to internal controls and reporting structure, and performing related duties as required.

Knowledge/Skills/Abilities

• Attention 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 & EXPERIENCE MINIMUM 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

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