Clinical Research Associate II – Senior Clinical Research Associate

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

📋 Description

• Oversee, evaluate, and finalize clinical trial investigator site assignments.

• Ensure the safety of patients and the quality of study implementation in compliance with applicable regulations, GCP, and Sponsor standards.

• Foster relationships with investigator sites to aid in enrollment, database access, site quality, compliance, and stakeholder involvement.

• Address protocol-related challenges and collaborate with the Site Care Partner and study team.

• Manage clinical trial processes from site initiation through to database locking.

• Act as the main point of contact for designated investigator sites and facilitate communication among study teams, vendors, and sites.

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

• Assist in recruitment efforts and manage site activation and recruitment challenges.

• Perform both onsite and remote/electronic monitoring for site initiation, routine oversight, and site closure.

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

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply details, study progress, and metrics.

• Identify and address site-related issues, developing corrective and preventive action plans.

• Resolve data inquiries and carry out investigator site close-out tasks.

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

• Assist with database access and assume unblinded monitoring responsibilities when necessary.

• Maintain knowledge of products, protocols, and therapeutic areas to support patient safety and eligibility.

• Aid in Quality Event remediation and implement audit corrective and preventive action measures.

⛳️ Requirements

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

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

• Proficiency in English and the native language(s) of the country where the work will take place.

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

• A valid driver's license and passport are mandatory.

• Bachelor's degree in life sciences or a professional degree in life sciences, such as nursing, pharmacy, or a medical background, or equivalent qualification.

🏝️ Benefits

• Equal opportunity employer.

• Travel reimbursement/support may be applicable for required business travel (not explicitly stated as a benefit).