Clinical Research Monitoring (CRA)

Clinical Research Associate I
Dell Medical School is seeking a Clinical Research Associate I. This is a state-funded position with an end date of August 31, 2027, renewable based on availability of funding, work performance, and progress toward 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.
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.
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.
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
$40,623 + depending on qualifications
Working Environment/Equipment

• Standard office equipment
• Repetitive use of a keyboard

Required Materials