Clinical Research Associate II/Senior Clinical Research Associate

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

📋 Description

• Manage relationships with investigator sites and oversee assigned clinical trial locations from the activation phase through database lock and close-out.

• Ensure that clinical trials adhere to the Study Monitoring Plan, relevant regulations, Good Clinical Practice (GCP), and Sponsor standards.

• Act as the main contact for designated investigator sites while coordinating communication between study teams and vendors.

• Provide coaching and training to site personnel on protocols, compliance, and patient safety measures.

• Assist in site activation, as well as initiatives for patient recruitment and enrollment.

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

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

• Submit Trial Master File (TMF) documentation, site reports, follow-up correspondence, protocol deviations, and track recruitment and study progress.

• Identify and address site-related issues, developing corrective and preventative actions as necessary.

• Resolve data queries and implement investigator site close-out activities.

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

• Support database release and, when applicable, undertake unblinded monitoring responsibilities.

• Maintain knowledge of products, protocols, and therapy areas while supporting patient safety and clinical guidance.

• Drive remediation of Quality Events and assist in audit Corrective and Preventative Action (CAPA) activities.

⛳️ Requirements

• A minimum of 2 years of relevant experience in clinical research site monitoring.

• In-depth knowledge of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.

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

• 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 professional degree in life sciences such as nursing, pharmacy, medical background, or an equivalent qualification.

🏝️ Benefits

• Equal opportunity employment.

• Flexibility for onsite, remote, or electronic monitoring as necessary.

• Investigator meetings may be conducted virtually or in person.