Senior Clinical Research Associate, French, Dutch

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Independently conduct, organize, and oversee clinical site monitoring activities.

• Evaluate protocol and regulatory compliance in line with company and sponsor procedures, ICH/GCP guidelines, and local regulations.

• Act as the main point of contact between the sponsor/Alimentiv and investigative sites.

• Implement clinical study plans effectively.

• Offer guidance and mentorship to CRA I and II teams.

• Perform and document onsite and remote monitoring, close-out, qualification, and initiation visits.

• Review study data against source documents and address or escalate data queries as needed.

• Coordinate the shipment of investigational products, laboratory supplies, ePROs, and study documentation.

• Instruct site personnel on protocols, study plans, systems, and ICH-GCP standards.

• Assess ISF and TMF for accuracy, timeliness, and completeness.

• Serve as the primary contact for questions and issues from investigational sites.

• Assist in site activation, recruitment milestones, communications, and study-system access.

• Engage in study meetings, investigator meetings, audits, and inspections.

• Mentor CRA I and II; conduct CRA assessments and co-monitoring visits.

• Contribute to process enhancement and best practice initiatives.

⛳️ Requirements

• 4–6 years of relevant experience.

• (Honors) Bachelor’s degree.

• Proficient in both written and spoken English.

• Equivalent combination of education and experience may be considered.

• Preferred degrees include Health Sciences, Life Sciences, Pharmacy, or Nursing, or Sr. CRA and/or ACRP Certification/Designation.

• Experience with Phase I–IV clinical trials is preferred.

• Comprehensive understanding of ICH-GCP and local regulatory standards.

• Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.

• Willingness to travel up to 40–60%, based on project assignments and the geographical location of sites.

• Strong interpersonal and problem-solving abilities; capable of working independently and collaboratively within cross-functional teams.

• Excellent communication and organizational skills, with a keen attention to detail and a sense of urgency.

• Must possess a valid driver’s license.

• Fluency in French and Dutch, as specified in the job title.

🏝️ Benefits

• One-time sign-on bonus of €3,000.

• Annual Bonus (Short Term Incentive Program) target = 8% of annual salary.

• Monthly stipend of €157.83 to cover communication-related business expenses (internet, VoIP, landline, etc.).

• Monthly cell phone allowance of €40.

• One-time reimbursement of up to €500 for purchasing office items such as a scanner/printer, additional monitor, office furniture, and supplies.

• Mileage reimbursement for travel expenses.

• Flexible remote work arrangement.