CRA - Monitor Great Lakes / Midwest

Clinical Research Associate

Location: Great Lakes/Midwest Region Type: Contract Hours: 20+ hours/week

Overview: Seeking an experienced Contract CRA/Study Monitor to oversee oncology clinical trial site management across the Great Lakes/Midwest region, ensuring protocol/GCP compliance, data integrity, and patient safety. This is a remote (offsite) contract role requiring ~60% travel and 5+ years of oncology monitoring experience; SOCRA/ACRP certification is a plus.

Responsibilities:

• General site management, including ensuring sites meet study qualifications, monitoring assigned study sites according to monitoring plans, ensuring timely data submission and query resolution.
• Conduct continuous monitoring activities (onsite and remote).
• Implement site management activities to ensure compliance with protocol, GCP, global, and local regulations to secure data integrity and patient safety.
• Serve as frontline liaison for Sponsor and sites to ensure successful collaboration.
• Respond to site questions and prepare reports.
• Prepare for and participate in calls/meetings as part of the study team matrix.
• Travel approximately 60% of the time; a valid driver's license is necessary.

Requirements:

• Strong healthcare-related background with a college degree or graduation from an accredited school of nursing.
• At least five years of oncology monitoring experience, including hematology study experience with multiple myeloma and small cell lung cancer backgrounds.
• Demonstrate professionalism, exemplary planning skills, and ability to work with autonomy and minimal supervision.
• Good communication skills, ability to identify key issues and trends, and effective problem-solving.
• Knowledge of ICH, GCP, safety, and other regulatory requirements; certification from SOCRA or ACRP is preferred.
• Computer competency and familiarity with data management systems (e.g., Medidata RAVE).