Job Title: Senior Clinical Research Associate (CRA)

Location: East Coast

Job Type: Contract

Start Date: January 2025

Length: 2 years

Hours: 30-40 hours per week

W2 ONLY!

Job Summary:

We are seeking a highly experienced and motivated Senior Clinical Research Associate (CRA) to join our dynamic team. The ideal candidate will have extensive experience in early phase (Phase 1 and 2) clinical trials, particularly in Oncology with a focus on Solid Tumors. This role involves overseeing clinical trial sites, ensuring compliance with protocols, and maintaining high standards of data integrity.

Key Responsibilities:

• Site Management: Oversee and manage clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Monitoring: Conduct regular site visits to monitor study progress, verify data accuracy, and ensure the safety and well-being of study participants.
• Data Entry and Management: Ensure accurate and timely entry of clinical data into electronic data capture systems. Review and verify data for completeness and consistency.
• Protocol Adherence: Ensure that clinical trials are conducted in accordance with the study protocol, SOPs, and regulatory requirements.
• Investigator Interaction: Serve as the primary point of contact for Principal Investigators (PIs) and site staff. Provide training and support to ensure proper conduct of the study.
• Documentation: Maintain comprehensive and accurate study documentation, including monitoring visit reports, regulatory documents, and correspondence.
• Issue Resolution: Identify and resolve site-related issues and discrepancies. Escalate significant issues to the Clinical Project Manager as needed.
• Collaboration: Work closely with cross-functional teams, including data management, regulatory affairs, and clinical operations, to ensure successful study execution.
• Compliance: Ensure all activities are conducted in compliance with applicable regulations, guidelines, and company policies.

Qualifications:

• Education: Bachelor's degree in a life science or related field. Advanced degree preferred.
• Experience: Minimum of 5 years of experience as a CRA, with significant experience in early phase (Phase 1 and 2) clinical trials in Oncology, specifically Solid Tumors.
• Skills: Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Excellent organizational and time management skills.
• Proficient in electronic data capture systems and clinical trial management systems.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Detail-oriented with a high level of accuracy.