Freelance Senior Clinical Research Associate

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

📋 Description

• Act as an operational member of a Project Team throughout the execution of clinical studies.

• Initiate, oversee both on-site and remotely, and conclude study sites.

• Provide unmasked Clinical Research Associate (CRA) support for designated clinical studies.

• Manage accountability of investigational products and supervise unblinded site activities.

• Ensure compliance with protocols, subject safety, data integrity, and data quality.

• Confirm adherence to informed consent procedures and protocol stipulations.

• Evaluate electronic or paper Case Report Forms (CRFs) and source documentation for correctness and reliability.

• Document actions taken during monitoring visits, findings, and any corrective/preventive measures; escalate deficiencies as necessary.

• Communicate identified issues and necessary action items to sites.

• Submit site documents to the electronic Trial Master File (eTMF) or paper Trial Master File (TMF).

• Ensure proper maintenance of the Investigator Site File in accordance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and local regulations.

• Update Clinical Trial Management System (CTMS) and other project systems with precise site-level information.

• Engage in the preparation and follow-up for audits and inspections.

• Order, ship, and reconcile clinical investigative supplies as needed.

• Support Clinical Research or Project Managers with project tracking, monitoring plans, review of monitoring reports, and management of CRA resources.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training for therapeutic areas when appropriate.

• Participate in capability presentations.

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing; or equivalent qualifications.

• Over 5 years of independent on-site monitoring experience.

• Minimum of 1 year experience as an unmasked monitor.

• Experience in ophthalmology is preferred, particularly in retina indications.

• Ability to thrive in a fast-paced environment with shifting priorities.

• Familiarity with basic medical terminology and the science related to assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Capability to work autonomously as well as collaboratively within a team matrix organization.

• Excellent written and verbal communication abilities.

• Proficient in English and the local language.

• Strong organizational skills.

• Technologically adept with solid software and computer skills.

• Attributes such as self-awareness, determination, adaptability, collaboration, proactivity, analytical mindset, attention to detail, coachability, motivation, facilitation of discussions, and diplomacy.

• Willingness to take ownership of assigned responsibilities.

• Competence in managing complex or early-phase studies.

• Readiness to travel up to 60–80%, including overnight and international journeys when necessary.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• Chance to make a positive impact on patients’ lives.

• Applications are encouraged from candidates belonging to protected categories under art. 1 L. 68/99.