Clinical Research Associate

Progressive; Brussel Hoofdstad; Sur place; EUR 52 000 - 75 000; Plein temps

Résumé du poste

Progressive in Belgium is seeking a Clinical Research Associate to manage study activities across multiple sites for MedTech projects. You will ensure high-quality data collection, safeguard participant safety, and act as liaison between clinical teams and site personnel.

The role requires collaboration with investigators, vendors, and internal stakeholders, adherence to GCP and regulations, and travel up to 80% to monitor sites and support training.

Qualifications

• Bachelor's degree with minimum two years of relevant experience, or a Master’s/PhD/MD/PharmD with at least one year of relevant experience.
• Previous clinical research experience is required.
• Experience in medical device monitoring or similar clinical monitoring activities is required.
• Professional certifications such as CCRA, RAC, or CDE are an advantage.

Responsabilités

• Monitor the safety and well-being of study participants at assigned sites.
• Conduct monitoring visits to ensure protocol adherence and data accuracy.
• Support the operational execution of clinical trials and data collection.
• Review Investigator Site Files to ensure regulatory compliance.
• Loster site performance, and coordinate with investigators and vendors.

Connaissances

Leadership

Communication

Presentation

Stakeholder mgmt

Project management

Multitasking

Microsoft Office

Formation

Bachelor's degree

Master's degree or higher (preferred)

Outils

Microsoft Office

Description du poste

As a Clinical Research Associate, you will be responsible for managing clinical study activities across multiple study sites within one or more clinical projects for the MedTech group. You will play a key role in ensuring the successful execution of clinical trials, maintaining high-quality data collection, and safeguarding the safety and well-being of study participants. Acting as the primary liaison between clinical study teams and site personnel, you will oversee site performance, conduct monitoring visits, support study execution, and contribute to the overall success of clinical research projects. This role requires strong collaboration with investigators, study coordinators, vendors, and internal stakeholders, while ensuring compliance with all applicable regulations, Good Clinical Practice (GCP) requirements, and company procedures.

Key responsibilities

• Ensure all activities and decisions reflect the organization's values and ethical standards.
• Monitor and verify the safety and well-being of study participants at assigned sites.
• Support the operational execution of clinical trials and ensure the collection of accurate, high-quality data.
• Conduct study activities in accordance with standard operating procedures, GCP guidelines, and regulatory requirements.
• Take ownership of study site performance and contribute to meeting overall project timelines.
• Identify, investigate, and resolve site-related issues while supporting corrective and preventive actions when needed.
• Review and maintain Investigator Site Files in line with regulatory and company requirements.
• Support patient recruitment and retention activities.
• Perform monitoring visits to ensure compliance with protocols, regulations, policies, and procedures.
• Communicate important clinical findings, site updates, and study events to relevant stakeholders.
• Assist in organizing investigator meetings and study-related training sessions.
• Provide accurate and up-to-date information regarding site status and study progress.
• Balance operational priorities with broader business objectives.
• Support the implementation of new clinical systems and processes.
• Collaborate with investigators, ethics committees, institutional review boards,
• vendors, contractors, and internal teams.
• Provide additional support to Clinical Operations activities as required.

Profile Education

• Bachelor's degree required.
• Preferred fields include Life Sciences, Biological Sciences, Physical Sciences, Nursing, or a related scientific discipline

Experience

• Bachelor's degree with a minimum of 2 years of relevant experience, or a
• Master's/PhD/MD/PharmD with at least 1 year of relevant experience.
• Previous clinical research experience is required.
• Experience in medical device monitoring or similar clinical monitoring activities is
• required.
• Solid understanding of clinical research regulations, standards, and medical device
• or combination product requirements.
• Professional certifications such as CCRA, RAC, or CDE are considered an
• advantage.
• Clinical or medical background is a plus.

Skills and competencies

• Strong leadership capabilities.
• Excellent written and verbal communication skills.
• Effective presentation and stakeholder influencing skills.
• Strong organizational and project management abilities.
• Ability to manage multiple priorities while meeting deadlines.
• Proficiency with Microsoft Office applications, including Excel, Word, and
• PowerPoint.
• Strong attention to detail and problem-solving skills.

What can you expect?

• An impactful role supporting innovative clinical research projects within the
• MedTech industry.
• Exposure to multiple clinical studies and collaboration with cross-functional teams.
• Opportunities to work closely with investigators, healthcare professionals, and
• research sites.
• Professional growth through involvement in complex clinical trials and new clinical
• processes and systems.
• Extensive field engagement, with travel requirements of up to 80% of working time.