Senior Clinical Research Associate

Senior Clinical Research Associate

VCLS - Voisin Consulting Life Sciences

Île-de-France, France

Description:

We are looking for a proactive and motivated Clinical Research Associate (CRA) to oversee clinical study monitoring and ensure that trials are conducted in full compliance with regulatory standards and guidelines.

Role:

• Identify and select suitable clinical trial sites based on study requirements;
• Conduct site initiation visits to ensure the research team is well-informed on the study protocol and regulatory requirements;
• Perform regular monitoring visits to clinical trial sites to confirm adherence to the study protocol, Good Clinical Practice (GCP), and regulatory guidelines;
• Carry out close-out visits once the trial concludes to verify the accuracy of data, completion of necessary documents, and submission of required reports;
• Draft visit reports and contribute to the study progress reports for the project team and sponsor;
• Train the principal investigator and site staff on the study protocol, documentation, and study procedures;
• Ensure that investigators comply with GCP standards;
• Serve as the main point of contact between the sponsor and the investigator, facilitating communication and collaboration;
• Ensure proper organization and maintenance of documents in the Investigator Site File;
• Retrieve essential documents required for the Trial Master File;
• Address site concerns promptly to prevent delays in the trial;
• Monitor patient enrollment and site performance to ensure timely inclusions;
• Oversee patient safety, ensuring adverse events (AEs) and serious adverse events (SAEs) are properly reported;
• Manage the distribution and return of materials and products at sites;
• Perform source data verification to ensure the accuracy and completeness of site data;
• Track study progress to ensure recruitment, data collection, and monitoring milestones align with study timelines;
• Assist in regulatory document reviews related to EU legal representation activities.

Requirements

• Bachelor’s degree in Life Sciences, Health, Pharmacy, or related field;
• Proficiency in GCP/ISO 14155 (valid certification required) and current regulations;
• At least 2 years of operational field experience as a CRA or a combination of CRA and other clinical research roles;
• Strong time management skills to handle multiple sites and responsibilities, with excellent multitasking abilities;
• Excellent verbal and written communication skills to liaise effectively between study sites and sponsors;
• Strong attention to detail and a problem-solving mindset.

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