Cardiac Clinical Research Associate — Study Site Lead

Amaris Consulting; Diegem; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a Clinical Research Associate to manage clinical activities across sites, focusing on cardiac electrophysiology. You will ensure data quality, regulatory compliance, and successful study execution. You will liaise with investigators, IRBs/ECs, vendors, and internal teams, while traveling up to 80% of the time.

Dutch and English proficiency are required, French preferred. Join a global environment with career progression, CSR initiatives, and access to internal

Qualifications

• Bachelor's degree with at least 2 years of relevant experience.
• Previous clinical research and medical device monitoring experience required.
• Understanding of regulations and standards in clinical research and medical devices/combination products.
• Relevant industry certifications (e.g., CCRA, RAC, CDE) preferred.
• English and Dutch proficiency; French is preferred.

Responsabilités

• Manage clinical study activities for multiple sites across single or several clinical projects.
• Oversee performance of appointed study sites, including site visits, monitoring, communication, and deliverables.
• Serve as the liaison between the clinical study team and study site personnel.
• Ensure the safety and well‑being of study subjects at assigned sites.
• Support operational execution of clinical trials and ensure collection of high‑quality, substantiated data.
• Execute clinical trial activities in compliance with SOPs, GCP, and regulatory requirements.
• Accountable for study site performance and data quality according to project timelines.
• Assist in resolving issues and implementing corrective/preventive actions as needed.
• Verify Investigator Site Files are maintained according to regulations and company procedures.
• Support patient recruitment and retention activities.
• Ensure study site compliance with protocols and all applicable regulations.
• Assist with internal communication of clinical data and events.
• Support organization of investigator and study training meetings.
• Act as a reliable resource for up‑to‑date study site status.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with investigators, IRBs/ECs, vendors, and company personnel.
• Comply with all applicable laws, regulations, and company policies.

Connaissances

Leadership

Communication

Presentation

Influencing

Formation

Bachelor's degree

Outils

Microsoft Office

Description du poste

Amaris Consulting is seeking a Clinical Research Associate to manage clinical activities across sites, focusing on cardiac electrophysiology. You will ensure data quality, regulatory compliance, and successful study execution. You will liaise with investigators, IRBs/ECs, vendors, and internal teams, while traveling up to 80% of the time.

Dutch and English proficiency are required, French preferred. Join a global environment with career progression, CSR initiatives, and access to internal