Clinical Research Associate – Freelance

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

📋 Description

• Oversee clinical trials both on-site and remotely in accordance with TFS and/or sponsor Standard Operating Procedures, GCP, ICH guidelines, and relevant regulatory requirements.

• Conduct all necessary monitoring activities at study sites to evaluate and ensure participant safety, data integrity, and quality.

• Ensure the protection of study participants through informed consent procedures and adherence to protocol requirements that comply with applicable regulations.

• Assess CRFs (whether electronic or paper) and subject source documentation for accuracy and validity.

• Confirm the proper management and accountability of Investigational Products.

• Promptly document actions taken during monitoring visits in the Monitoring Visit Report, which includes findings, corrective and preventive actions taken, and updates to relevant tracking systems as necessary; escalate any deficiencies and issues as appropriate.

• Provide the site with a list of issues identified during monitoring visits and the action items that need to be addressed promptly.

• Ensure timely delivery of site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in compliance with GCP, ICH guidelines, and local regulatory standards.

• Engage in audit and/or inspection activities, including preparation and follow-up tasks as needed.

• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.

• Update CTMS and all other project-required systems with accurate site-level information.

⛳️ Requirements

• Bachelor’s Degree, ideally in life sciences or nursing; or an equivalent qualification.

• More than 1 year of relevant clinical experience or pertinent academic background in clinical trials or clinical development activities.

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

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

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Experience with cardiovascular studies involving Medical Devices is a significant advantage.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.