Clinical Research Associate: Toulouse / Montpellier

TN France; France; À distance; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An innovative company in the clinical research field is seeking a Clinical Research Associate to join their dynamic team. This role offers the opportunity to engage in vital clinical monitoring activities, ensuring the highest quality standards while working on groundbreaking oncology and hematology trials. As a key player, you will collaborate closely with various stakeholders, drive excellence in clinical operations, and contribute to impactful research that fights cancer. If you are a motivated professional with a passion for improving patient outcomes and possess strong communication skills, this position could be your next career milestone.

Qualifications

• 2-4 years of CRA monitoring experience in pharma or CRO.
• Fluent in English and French, both spoken and written.

Responsabilités

• Execute clinical monitoring activities at trial sites according to ICH and GCP.
• Conduct monitoring visits and complete reports per BeiGene standards.
• Collaborate with the Regional Clinical Operations Manager to ensure study timelines.

Connaissances

Clinical Trial Processes

Communication Skills

Organizational Skills

Multitasking

Analytical Thinking

Problem-Solving

Formation

Bachelor's Degree in Life Sciences

Outils

MS Word

MS Excel

MS Project

PowerPoint

Outlook

Description du poste

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Clinical Research Associate: Toulouse / Montpellier, remote, france

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Client:

BeiGene

Location:

France (Toulouse / Montpellier)

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

af166d80c2f3

Job Views:

2

Posted:

03.05.2025

Expiry Date:

17.06.2025

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Job Description:

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.

May be assigned to CRA activities or start-up activities, depending on experience and project needs.

Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.

Identify gaps and areas for improvement and propose CAPA.

Supports start-up and provides local expertise.

The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.

CRA activities include:

• Perform feasibility, site identification, selection and evaluation, preparing/supporting initial list of sites and recruitment targets.
• Provide protocol and related study training to assigned sites.
• Conduct monitoring visits (pre-study, initiation, routine, closeout) per monitoring plan and SOPs.
• Complete monitoring visit reports in accordance with ICH-GCP, BeiGene standards, and SOP.
• Manage sites and site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
• Establish regular communication with sites and report progress, issues, and actions.
• Ensure inspection readiness of the study and sites.
• Collaborate with the Regional Clinical Operations Manager and sites to ensure timely delivery of milestones.
• Attend training as required.
• Facilitate Study Oversight Visits (SOVs), site audits, and inspections.
• Evaluate site practices and escalate issues as needed.
• Identify site issues; propose corrective actions; seek continuous improvement.

Computer Skills: Proficiency in MS Word, Excel, MS Project, PowerPoint, Outlook, and other relevant tools.

Qualifications:

• Understanding of clinical trial processes, ICH, and regulatory guidelines.
• Ideally 2-4 years of CRA monitoring experience in pharma or CRO.
• Excellent communication, interpersonal, organizational, and multitasking skills.
• Fluent in English and French (spoken and written).
• Travel up to 60%.

Additional competencies include ethics, planning, communication, teamwork, adaptability, technical skills, dependability, quality focus, analytical thinking, problem-solving, and project management. Our core values are Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, fostering teamwork, honest feedback, and continuous improvement.