Clinical Research Associate

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

📋 Description

• Oversee clinical trial investigator sites, encompassing site management, monitoring, and closure activities.

• Ensure the safety of patients and the quality of study execution in line with relevant laws, Good Clinical Practice (GCP), and sponsor guidelines.

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

• Act as the main point of contact for assigned investigator sites and coordinate with Site Care Partners, study teams, vendors, and site staff.

• Provide development support for sites, including coaching, training, protocol education, and recruitment assistance.

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

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

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

• Identify and address site-related issues; devise corrective and preventative actions.

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

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

• Assist with database release and, when necessary, fulfill unblinded monitoring responsibilities.

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

• Propel quality-event remediation and audit Corrective and Preventative Action (CAPA) activities when applicable.

⛳️ Requirements

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

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

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

• 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, medical background, or an equivalent qualification.

🏝️ Benefits

• Equal opportunity for employment consideration without regard to legally protected status.

• Travel allowance as necessitated by role travel requirements (specific compensation not detailed).