Senior Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in California.

📋 Description

• Deliver exceptional care to participants involved in clinical trials and respond effectively to emergency situations in line with clinical research standards.

• Conduct routine monitoring and finalization of clinical sites.

• Organize and maintain study documentation.

• Execute pre-study and initiation visits.

• Collaborate with vendors.

• Oversee study sites in accordance with project plans.

• Ensure that study staff are equipped with the necessary materials and instructions to safely enroll patients in the study.

• Confirm that informed consent processes and protocol specifications adhere to relevant regulatory standards.

• Validate the accuracy of data provided in Case Report Forms and other data collection instruments.

• Monitor data to identify any missing or implausible entries.

• Manage registries in alignment with project plans and undertake feasibility assessments as needed.

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

• Independently perform CRF reviews, generate queries, and resolve issues utilizing Fortrea or client data management systems.

• Assist in training new team members through co-monitoring activities.

• Coordinate specific clinical projects as a Local Project Coordinator and may serve as a local contact for clients.

• Execute additional responsibilities as assigned by management.

• Travel frequently to client and site locations, including occasional domestic and international trips.

⛳️ Requirements

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

• Over 5 years of experience in Clinical Monitoring.

• Experience in oncology; early phase experience is preferred.

• Willingness to travel overnight 30-50% of the time.

• Comfortable working in a dynamic environment with stringent study protocols and timelines.

• Ability to adjust to frequently shifting priorities.

• Strong teamwork and interpersonal skills.

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

• Capability to sit for prolonged periods and operate a vehicle securely.

• Repetitive hand movements with both hands, able to perform quick, simple, repeated motions with fingers, hands, and wrists.

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

• Proficient in accessing and utilizing a variety of computer software, both custom-built and commercial.

• Light to moderate lifting and carrying of items, including luggage and a laptop, with a maximum weight of 15-20 lbs.

• Regular and reliable attendance is essential.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and training.

• Flexible working arrangements.

• Supportive and collaborative work environment.