Clinical Project Associate

Syneos Health, Inc.; Machelen; On-site; EUR 45,000 - 60,000; Full time

Job summary

Jobtailor in Belgium is seeking a Clinical Operations Assistant to support monitoring activities, maintain the Trial Master File (TMF) and project files, and assist with site management tasks. You will coordinate documentation, prepare site manuals and reference tools, manage incoming and outgoing regulatory documents, and support team meetings to ensure protocol compliance across assigned studies.

Fluency in Dutch, English and French will help you liaise with sites and cross-functional teams,

Qualifications

• Master's degree in biomedical sciences or related.
• Strong interest in clinical research.
• Good communication and interpersonal skills.
• Fluency in Dutch, English and French.
• Ability to embrace new technologies.
• Ability to work from the office in the Machelen/Zaventem region on a regular basis.

Responsibilities

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, SOPs and Work Instructions.
• Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
• Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
• Prepare and maintain site manuals, reference tools and other documents.
• Maintain, update, and input clinical tracking information into databases.
• Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manage shared mailbox, process site requests and route correspondence appropriately.
• Coordinate the ordering, packaging, shipping and tracking of site supplies and materials.
• Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.

Skills

Strong interest in clinical research

Good communication and interpersonal

Fluency in Dutch, English and French

Ability to embrace new technologies

Office-based work in Machelen/Zaventem

Education

Master's degree in biomedical sciences or related

Job description

Responsibilities

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepare and maintain site manuals, reference tools and other documents
• Maintain, update, and input clinical tracking information into databases
• Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manage shared mailbox, process site requests and route correspondence appropriately
• Coordinate the ordering, packaging, shipping and tracking of site supplies and materials
• Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintain overall awareness in the field of clinical research by completing all necessary and assigned training

Requirements

• Master degree in biomedical sciences or related
• Strong interest in clinical research
• Good communication and interpersonal skills
• Fluency in Dutch, English and French
• Ability to embrace new technologies
• Ability to work from the office in the Machelen/Zaventem region on a regular basis