Clinical Research Associate II/Sr. Clinical Research Associate

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

📋 Description

• Oversee the management, monitoring, and closure of assigned clinical trial investigator sites.

• Ensure the safety of patients and the quality execution of studies in compliance with applicable laws, GCP, and Sponsor standards.

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

• Act as the primary contact for assigned investigator sites.

• Facilitate the flow of information among study team members, vendors, and investigator sites.

• Provide development, coaching, training, and protocol support to sites.

• Assist with enrollment and recruitment efforts.

• Conduct both onsite and remote/electronic monitoring for site initiation, routine checks, and closure.

• Monitor adverse events and serious adverse events, collaborating with the Drug Safety Unit.

• Submit necessary reports, TMF documentation, site reports, protocol deviations, and study metrics.

• Identify and address site issues, developing corrective and preventative actions as needed.

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

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

• Support database release and, when necessary, take on unblinded monitoring responsibilities.

• Maintain knowledge of products, protocols, and therapy areas to ensure patient safety and provide clinical guidance.

• Lead Quality Event remediation and CAPA activities in response to audit observations when applicable.

⛳️ Requirements

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

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

• Proficiency in English and the native language(s) of the respective country.

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

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

• A Bachelor’s degree in life sciences or a professional degree in fields such as nursing, pharmacy, or a related medical background is essential.

🏝️ Benefits

• An equal opportunity employer.

• Qualified applicants will be considered for employment regardless of legally protected status.