Senior Clinical Research Associate

Actalent; Brussel; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Actalent seeks a Senior Clinical Research Associate to oversee clinical study activities within a MedTech environment. The role involves monitoring sites, ensuring data quality, and maintaining regulatory compliance across projects.

The ideal candidate has a Life Sciences degree, at least 4 years of CRA site-monitoring experience, and proficiency in GCP. Travel up to 80% is required; English and Dutch language skills are mandatory.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 4 years of recent site monitoring experience as a CRA.
• Medical device or MedTech monitoring experience.
• Strong knowledge of GCP and clinical research regulations.
• Certifications such as CCRA, RAC, or CDE are desirable.
• Fluency in English and Dutch is required.

Responsabilités

• Manage clinical study activities for assigned study sites across one or more clinical projects.
• Conduct site monitoring visits and maintain regular communication with site personnel.
• Ensure patient safety and wellbeing are maintained throughout the study.
• Support the operational execution of clinical trials and ensure collection of high-quality data.
• Verify Investigator Site Files are maintained according to regulatory and company requirements.
• Support patient recruitment and retention activities.
• Identify, elevate, and assist in resolving site-related issues.
• Ensure compliance with study protocols, regulatory requirements, and company procedures.
• Collaborate with investigators, ethics committees, vendors, and internal stakeholders.
• Serve as a reliable source of study site status and progress updates.
• Support implementation of new clinical systems and processes.

Connaissances

Site monitoring

GCP compliance

Communication

Organization

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

Our client, a global leader in the MedTech industry, is looking for a Senior Clinical Research Associate to support clinical study activities within a MedTech environment.

The successful candidate will be responsible for managing clinical activities at study sites conducting clinical studies, while building strong and productive relationships with internal stakeholders and site personnel. This role involves overseeing study site performance, conducting monitoring visits, and ensuring high-quality data collection in compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.

Responsibilities

• Manage clinical study activities for assigned study sites across one or more clinical projects
• Conduct site monitoring visits and maintain regular communication with site personnel
• Ensure patient safety and wellbeing are maintained throughout the study
• Support the operational execution of clinical trials and ensure collection of high-quality data
• Verify Investigator Site Files are maintained according to regulatory and company requirements
• Support patient recruitment and retention activities
• Identify, elevate, and assist in resolving site-related issues
• Ensure compliance with study protocols, regulatory requirements, and company procedures
• Collaborate with investigators, ethics committees, vendors, and internal stakeholders
• Serve as a reliable source of study site status and progress updates
• Support implementation of new clinical systems and processes

Requirements

• Bachelor's degree in Life Sciences, Biological Sciences, Nursing, Physical Sciences, or a related field
• Minimum 4 years of recent site monitoring experience as a CRA
• Previous clinical research experience
• Medical device or MedTech monitoring experience
• Strong knowledge of GCP and clinical research regulations
• Relevant certifications such as CCRA, RAC, or CDE are desirable
• Strong communication, presentation, and organizational skills
• Ability to manage multiple priorities and deadlines
• Willingness to travel up to 80%
• Fluency in English and Dutch is required