Clinical Research Associate II/Sr. Clinical Research Associate

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

📋 Description

• Oversee the management, monitoring, and completion of designated clinical trial investigator sites.

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

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

• Act as the primary liaison for assigned investigator sites while collaborating with Site Care Partners and study teams.

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

• Train and mentor site personnel on study protocols and compliance requirements.

• Assist with site activation, patient recruitment, enrollment, and investigator meetings.

• Perform onsite and remote/electronic site initiation, routine monitoring, and close-out activities.

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

• Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics.

• Identify and resolve issues at sites while developing corrective and preventive action plans.

• Address data queries and prepare for site close-out activities.

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

• Support database release and conduct unblinded monitoring when necessary.

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

• Lead Quality Event remediation and audit observation CAPA activities as required.

⛳️ Requirements

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

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

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

• 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 life sciences such as nursing, pharmacy, or a medical background, or an equivalent qualification.

• Capacity to conduct onsite and remote/electronic monitoring.

• Familiarity with protocols, therapy areas, patient safety, eligibility criteria, and clinical guidance.

• Location specified as United States/Arizona/Remote United States.

🏝️ Benefits

• Equal opportunity employment considerations regardless of legally protected status.

• Opportunity to contribute to therapies that benefit patients and enhance global health.