Clinical Research Associate II / Senior CRA

University Positions; Lille; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player is seeking proactive Clinical Research Associates to enhance their growing team in France. This role involves managing relationships with clinical sites, ensuring compliance with protocols, and driving project goals to completion. You will be at the forefront of clinical trials, collaborating with investigators and site staff to address challenges and improve study integrity. The ideal candidate will possess strong communication skills and a solid background in clinical research, ready to make a significant impact in the healthcare sector. Join a team dedicated to improving global health outcomes through innovative solutions.

Qualifications

• Experience in site management or equivalent clinical research.
• Degree in biological sciences or related health discipline.

Responsabilités

• Act as primary contact with sites, ensuring protocol adherence.
• Evaluate site staff assignments and implement corrective actions.
• Manage study supplies, site payments, and data entry.

Connaissances

Problem-solving

Client-focused skills

Strong communication

Time management

Computer skills

Ability to work across cultures

Flexibility for travel

Formation

Degree in biological sciences

Pharmacy degree

Equivalent nursing qualification

Description du poste

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Due to an expanding portfolio, we are currently looking for several CRA II or Senior CRAs for our team in France.

Key Accountabilities :

Start-up (from site identification through pre-initiation):

• Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Conduct, drive and manage country-specific feasibility and/or site pre-qualification and qualification activities, which may include :
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
• Develop strategy to configure, distribute, review, and approve high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations, and amendments.
• Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and following up until final approval.
• Manage documentation submission to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval, site activation, and update Clinical Trial Management systems (CTMS) timely.
• Identify, address, and resolve site questions/issues, including risks with site activation, recruitment, training deficiencies, data quality, or compliance.
• Support sites with access to relevant study systems and ensure compliance with training requirements prior to study start.
• Participate in investigator meetings, audits, and regulatory inspections.
• Work independently with limited oversight and keep management informed about progress and issues.

Maintenance (from initiation through close-out):

• Act as the primary contact with sites, ensuring study integrity and adherence to protocols.
• Build and maintain relationships with investigators and site staff.
• Evaluate site staff assignments and implement corrective actions if needed.
• Address and resolve site issues, including training needs, documentation, and communication.
• Conduct on-site visits, remote contacts, and generate reports.
• Assess site compliance and performance, providing recommendations for improvements.
• Manage study supplies, site payments, and data entry/query follow-up.
• Recognize and communicate study non-compliance or delays.

Overall Accountabilities :

• Ensure timely and accurate project goal completion and system updates.
• Collaborate with team members, ensure audit readiness, and maintain compliance with regulations.
• Delegate tasks appropriately and maintain a high-quality work environment.
• Develop expertise and work proactively with minimal oversight.

Skills :

• Problem-solving, initiative, presentation, and client-focused skills.
• Strong communication, time management, and computer skills.
• Ability to work across cultures and in a virtual team environment.
• Flexibility for travel and a valid driver’s license if required.

Knowledge and Experience :

• Site management or equivalent clinical research experience.

Education :

• Degree in biological sciences, pharmacy, or related health discipline, or equivalent nursing qualification or experience.