Senior Clinical Research Associate

VCLS; Boulogne-Billancourt; Sur place; EUR 35 000 - 55 000; Plein temps

Résumé du poste

A leading company is seeking a proactive Clinical Research Associate (CRA) to oversee clinical study monitoring in compliance with regulatory standards. The role involves site selection, training, and ensuring adherence to Good Clinical Practice (GCP). Candidates should have a Bachelor's degree in a relevant field and at least 2 years of experience in clinical research.

Qualifications

• At least 2 years of operational field experience as a CRA or in related clinical research roles.
• Proficiency in GCP/ISO 14155 with valid certification required.

Responsabilités

• Oversee clinical study monitoring and ensure compliance with regulatory standards.
• Conduct site initiation and monitoring visits, and manage patient safety.
• Serve as the main contact between sponsor and investigator.

Connaissances

Time Management

Communication

Attention to Detail

Problem Solving

Formation

Bachelor’s degree in Life Sciences, Health, Pharmacy, or related field

Description du poste

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

· 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.