Clinical Research Associate

Rede Optimus; Antwerpen; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Rede Optimus is seeking a (Jr/Sr.) Clinical Research Associate located in Belgium to support clinical investigations across all phases of protocol execution. The role involves document development, regulatory submissions, site contracts, training, and monitoring activities.

The candidate should have completed studies in medicine, pharmacy, or a related natural science, be fluent in English and Dutch, and willing to travel regularly across Europe.

Qualifications

• Successfully completed studies in medicine, pharmacy, biochemistry or a comparable natural science discipline.
• Willing to learn the required medical topics and applicable regulatory guidelines.
• Fluent in English and Dutch; knowledge of French is a valuable asset.
• Mastered the common software packages (Word, Excel, PowerPoint, Adobe).
• An independent working environment and deadlines does not scare you.
• Willing to travel around Europe on a regular basis.
• Knowledge of GCP, completed Good Clinical Practice training is an advantage

Responsibilities

• Assist with development of specific study documents for clinical investigations during all phases of protocol execution (start-up, maintenance and study closure).
• Draft and submit study documents to Competent Authorities and Ethics committees.
• Assist Project Manager with development and negotiation of site contracts.
• Train site staff on procedures, source documentation, and CRF completion under PM supervision.
• Create site selection questionnaires.
• Support administrative tasks within clinical trials.
• Review study progress, data quality, patient compliance, and investigational product accountability; ensure GCP compliance.
• Conduct regular site visits, coordinate project meetings, and write visit-specific reports.
• Conduct remote monitoring activities and follow-up on safety events.
• Support Trial Master File and Site Master File preparation and maintenance

Skills

Fluent English

Fluent Dutch

Travel Europe

Independent worker

Deadline-oriented

Education

Medicine

Pharmacy

Biochemistry

Natural sciences degree

Tools

Word

Excel

PowerPoint

Adobe

Job description

(Jr/Sr.) Clinical Research Associate (located in Belgium)

Job duties:

• Assist with development of specific study documents for clinical investigations during all phases of the protocol execution (start-up, maintenance and study closure);
• Draft and submit study documents to the Competent Authorities and Ethic committees;
• Assist Project Manager with the development, negotiation, execution of the site contract;
• Train site staff on study procedure, proper source documentation, and case report form completion under supervision of PM;
• Helps with creating site selection questionnaires;
• Support in all administrative tasks within clinical trials;
• Able to review study progress, the quality and accuracy of data collection, compliance of patients to trial visits and assessments, and investigational product accountability (If applicable), and ensure good clinical practices are maintained throughout the trial and offer direction to the site when needed;
• Conduct regular site visits, coordinating project meetings, and writing visit specific reports;
• Conduct remote monitoring activities and follow-up on safety events;
• Support in Trial Master File and Site Master File preparation and maintenance

Expectations/Qualifications:

• Successfully completed studies in medicine, pharmacy, biochemistry or a comparable natural science discipline;
• Willing to learn the requires medical topics and the applicable regulatory guidelines;
• Fluent in English and Dutch. Knowledge of additional languages such as French are a valuable asset;
• Mastered the common software packages (Word, Excel, Powerpoint, Adobe);
• A thoughtful employee with a sense of initiative and organization;
• An independent working environment and deadlines does not scare you;
• Willing to travel around Europe on a regular basis;
• Stress resistant, work accurately, with a healthy dose of creativity and flexibility;
• Knowledge of GCP, completed Good Clinical Practice training is an advantage

Compensation:

We offer you a monthly market-compliant salary within a growing research company.

Home based or office based can be discussed.