Clinical Research Associate I

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.

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.

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/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

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