Senior Clinical Research Associate II - Oncology

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

📋 Description

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

• Carry out routine monitoring and closure of clinical sites.

• Maintain study documentation and conduct pre-study and initiation visits.

• Collaborate with vendors and execute other assigned responsibilities.

• Oversee study sites in accordance with project plans.

• Ensure study personnel receive appropriate materials and guidance.

• Confirm that informed consent processes and protocol requirements adhere to relevant regulations.

• Safeguard the integrity of submitted Case Report Forms and other data collection instruments via source-document reviews.

• Monitor data for any missing or implausible entries.

• Manage registries and carry out feasibility assessments upon request.

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

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

• Assist in training new staff through activities such as co-monitoring.

• Coordinate specified clinical projects as a Local Project Coordinator and may also serve as a local client contact.

• Travel frequently to client and site locations, which may include occasional domestic and international trips.

⛳️ Requirements

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

• Over 5 years of experience in Clinical Monitoring.

• Experience in oncology; early phase experience is preferred.

• Willingness to undertake 30–50% overnight travel.

• Adaptability to thrive in a fast-paced, continuously evolving, technology-driven environment.

• Strong teamwork and interpersonal skills.

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

• Ability to perform repetitive hand movements with both hands, executing quick, simple, repetitive motions of the fingers, hands, and wrists.

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

• Proficiency in accessing and utilizing various software applications developed both in-house and commercially.

• Ability to lift and transport items, including luggage and a laptop, with a maximum lifting capacity of 15–20 lbs.

• Regular and consistent attendance is expected.

• Flexibility to work varied hours.

🏝️ Benefits

• Designation for remote work.

• Opportunities for 30–50% overnight travel.

• Continuous acceptance of applications.