Senior Clinical Research Associate - FSP

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

📋 Description

• Oversee site management, monitoring, and closure of designated clinical trial investigator sites.

• Ensure patient safety and the quality execution of studies in compliance with relevant laws, GCP, and sponsor standards.

• Manage relationships with investigator sites and operational procedures from site activation to database lock.

• Act as the main point of contact for assigned investigator sites.

• Facilitate communication among study team members, vendors, and investigator sites.

• Provide coaching and training to site personnel, including protocol education.

• Assist with enrollment and address site activation and recruitment challenges.

• Perform onsite and remote/electronic monitoring for site initiation, ongoing monitoring, and closure activities.

• Track and monitor adverse events and serious adverse events in collaboration with the Drug Safety Unit.

• Submit trial documentation, reports, tracking, and study metrics within specified timelines.

• Identify and resolve issues at investigator sites and implement corrective and preventive actions.

• Address data queries and carry out investigator site close-out procedures.

• Oversee the receipt, handling, storage, accounting, and disposal of investigational products.

• Support the release of databases and, when applicable, take on unblinded monitoring responsibilities.

• Maintain knowledge of products, protocols, and therapy areas to support patient safety and investigator guidance.

• Lead quality event remediation efforts and assist with audit observation CAPA activities.

⛳️ Requirements

• Comprehensive understanding of clinical trial methodologies, ICH/GCP, FDA guidelines, and local regulations.

• At least 2 years of relevant experience in clinical research site monitoring.

• Proficiency in English and the native language(s) of the country of employment is essential.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are required.

• Bachelor’s degree in life sciences or equivalent professional degree in life sciences such as nursing, pharmacy, or medicine.

🏝️ Benefits

• Commitment to equal opportunity employment.

• Travel reimbursement or other travel-related compensation is not explicitly mentioned.