Job Description

NIH Contract CRA Project - 40 hours per week. 4 month with extension to July 2026.

Phase I - Oncology.

on site visits on Bethesda. Remote one doing site visits.

W2/1099

Job Summary:

We are seeking a detail-oriented and experienced Clinical Research Associate (CRA) to monitor and manage Phase 1 Oncology clinical trials. The CRA will ensure the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This position involves collaborating with investigators, site personnel, and cross-functional teams to ensure the safety and well-being of participants in early-phase clinical trials.

Key Responsibilities:

• Site Management and Monitoring:
• Conduct site qualification, initiation, interim monitoring, and close-out visits.
• Ensure proper site adherence to protocols, GCP, and regulatory requirements.
• Verify and ensure accurate data collection and reporting.
• Assess site performance and provide corrective actions if necessary.
• Regulatory Compliance:
• Ensure all clinical trial documentation is maintained according to regulatory guidelines.
• Review informed consent documents and confirm proper consenting procedures.
• Collaborate with regulatory teams to ensure timely submissions and approvals.
• Safety and Data Management:
• Monitor and report adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities.
• Validate source data and resolve data discrepancies.
• Ensure timely and accurate documentation of clinical trial data in electronic data capture (EDC) systems.
• Collaboration and Communication:
• Build and maintain relationships with study investigators and site staff.
• Communicate study updates and findings to study sponsors and internal teams.
• Provide training to site personnel on study protocols, procedures, and GCP compliance.

Qualifications:

• Bachelor’s degree in Life Sciences , Nursing , or a related field.
• At least 2-4 years of experience as a Clinical Research Associate in oncology trials, with preference for Phase 1 experience.
• Strong knowledge of Good Clinical Practice (GCP) , FDA regulations, and ICH guidelines.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, problem-solving, and communication skills.

Preferred Qualifications:

• Previous experience in early-phase oncology trials (e.g., dose escalation studies, first-in-human trials).
• Strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments.
• Certification as a Clinical Research Professional (CCRA) is a plus.

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