Senior Clinical Research Associate, French, Dutch

• Independently perform, coordinate and oversee clinical site monitoring services
• Assess protocol and regulatory compliance according to company and sponsor processes, ICH/GCP guidelines and local regulations
• Serve as the primary liaison between the sponsor/Alimentiv and investigative sites
• Execute clinical study plans
• Provide guidance and mentoring to CRA I and II
• Conduct and document onsite and remote site monitoring, close-out, qualification and initiation visits
• Review study data against source documents and resolve or escalate data queries
• Coordinate shipment of investigational products, laboratory supplies, ePROs and study documents
• Train site staff on protocols, study plans, systems and ICH-GCP
• Review ISF and TMF for accuracy, timeliness and completeness
• Act as primary contact for investigational-site questions and issues
• Support site activation, recruitment milestones, communications and study-system access
• Participate in study meetings, investigator meetings, audits and inspections
• Mentor CRA I and II; perform CRA assessment and co-monitoring visits
• Participate in process improvement and best-practice initiatives

• 4–6 years of related experience
• (Honors) Bachelor’s degree
• Fluent in written and verbal English
• Equivalent combination of education and experience may be considered
• Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr. CRA and/or ACRP Certification/Designation
• Experience with Phase I–IV clinical trials preferred
• Thorough knowledge of ICH-GCP and local regulatory requirements
• Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite
• Ability to travel up to 40–60%, depending on project assignment and geographic location of sites
• Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams
• Great communication and organizational skills, detailed orientation and sense of urgency
• Holder of a valid driver’s license
• Fluent French and Dutch, as indicated by the job title

• 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 offset business use of communication costs (internet, VoIP, land line, etc.)
• Monthly cell phone stipend of €40
• One-time expense reimbursement of up to €500 to purchase office items such as a scanner/printer, extra monitor, office furniture and supplies
• Mileage reimbursement for travel
• Remote work arrangement