Clinical Research Associate II

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

📋 Description

• Oversee, monitor, and conclude activities at designated clinical trial investigator sites.

• Ensure the safety of patients and the quality of study implementation in compliance with relevant laws, GCP, and sponsor guidelines.

• Manage relationships with investigator sites and handle 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 coaching, training, and protocol support to site personnel.

• Assist in site activation, recruitment efforts, and enrollment processes.

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

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

• Submit necessary TMF documentation, site reports, follow-up letters, protocol deviations, and updates on recruitment and study progress.

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

• Resolve data queries and perform close-out activities for investigator sites.

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

• Support database releases and unblinded monitoring when appropriate.

• Maintain knowledge of products, protocols, and therapy areas.

• Ensure patient safety, eligibility, and provide clinical guidance.

• Drive remediation of Quality Events and manage audit CAPA activities when necessary.

⛳️ Requirements

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

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

• Proficiency in English and the native language(s) of the country in which work will be performed.

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

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

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

🏝️ Benefits

• Equal opportunity employment.

• Travel allowance covered by the required travel (no explicit benefit stated).