Senior Clinical Research Associate – Oncology, CAR T

This is a fully remote position, open to applicants in Arizona, +26 more states.

📋 Description

• Direct and assist the Full Service Outsourcing team collaborating with various sponsors.

• Deliver a high level of care for participants in clinical trials and react to emergency situations in accordance with clinical research standards.

• Execute routine monitoring and close-out procedures for clinical sites.

• Organize and maintain study files.

• Carry out pre-study and initiation visits.

• Communicate effectively with vendors.

• Oversee study sites in alignment with project plans.

• Ensure study staff are equipped with the necessary materials and instructions for safely enrolling patients in the study.

• Confirm informed consent procedures and protocol requirements align with relevant regulatory standards.

• Safeguard data integrity on Case Report Forms and other data collection instruments through thorough source document reviews.

• Monitor data for any missing or implausible entries.

• Manage registries and perform feasibility studies when requested.

• Complete reporting for Serious Adverse Events, including reports, narratives, and follow-up actions.

• Independently conduct CRF reviews and generate/resolve queries utilizing Fortrea or client data management systems.

• Support the training of new employees through co-monitoring initiatives.

• Coordinate specific clinical projects as a Local Project Coordinator, with necessary supervision.

• Serve as a local client contact as designated.

• Execute additional responsibilities as assigned by management.

• Travel up to 60–70%, which includes 8–10 days on-site each month and occasional domestic and international travel.

⛳️ Requirements

• A university or college degree, or certification in a related allied health profession from an accredited institution (e.g., nursing licensure).

• At least 1 year of experience in Clinical Monitoring.

• Experience in oncology is preferred.

• Open to various hub locations.

• Comfortable in a fast-paced, protocol-driven setting.

• Capable of prioritizing tasks and adjusting to shifting priorities.

• Strong teamwork and interpersonal skills.

• Proficient in working within a technology-driven electronic data environment.

• Ability to sit for extended durations and operate a vehicle safely.

• Repetitive hand movements with both hands, including the capability for quick, simple, repeated motions of the fingers, hands, and wrists.

• Occasional crouching, stooping, and frequent bending and twisting of the upper body and neck.

• Competent in accessing and utilizing various computer software.

• Light to moderate lifting and carrying, inclusive of luggage and a laptop computer, weighing up to 15–20 lbs.

• Consistent and regular attendance is required.

• Varied working hours may be necessary.

🏝️ Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers).

• 401(K) plan.

• Paid time off (PTO) with a Flex Plan.

• Employee recognition awards.

• Multiple Employee Resource Groups (ERGs).