Senior Clinical Research Associate

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

📋 Description

• Execute site monitoring duties for clinical trials

• Offer oversight, leadership, and direction in the management and execution of clinical trials to ensure adherence to compliance and quality standards

• Ensure timely and appropriate visits to investigator sites

• Provide guidance, oversight, and feedback to the CRA team to guarantee compliance with project scope, standard operating procedures (SOPs), timelines, and budgetary requirements

• Review monitoring visit reports and conduct co-monitoring and evaluation visits as necessary

• Consistently prepare accurate and timely monitoring visit reports that document site-related issues, resolutions, actions taken, protocol deviations, study progress, and enrollment status

• Participate in internal, client/sponsor, scientific, and other required meetings

⛳️ Requirements

• US: Bachelor’s degree (BS/BA) from an undergraduate program, preferably in life sciences or a related field

• US: A minimum of 3 years of experience in the pharmaceutical, biotechnology, or CRO industry, including 2 years in clinical monitoring and 1 year in a management role

• EU: At least 2 years of clinical monitoring experience within the pharmaceutical, biotechnology, or CRO sector, with the capacity to independently manage monitoring activities

• Proficient command of English, both written and spoken

• Proficient command of the local language, both written and spoken, in the country where monitoring activities occur

• Permanent authorization to work in the U.S.

• Certified Monitor in accordance with the Italian CRO decree dated November 15, 2011.

🏝️ Benefits

• Opportunities for professional development

• Chance for global travel

• Flexible work programs