Senior Clinical Research Associate, Germany

• 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
• Conduct and document onsite and remote monitoring, close-out, qualification, and initiation visits
• Review study data against source documents and resolve or escalate data queries
• Coordinate shipment and delivery 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, study communications, and project timelines
• Participate in study meetings, investigator meetings, audits, and inspections
• Mentor CRA I and II and perform CRA assessment or co-monitoring visits
• Support hiring interviews and process improvement initiatives

• 4–6 years of related experience
• (Honors) Bachelor’s degree
• Fluent in written and verbal English
• An equivalent combination of education and experience may be considered
• Thorough knowledge of ICH-GCP and local regulatory requirements
• Proficiency with EDC systems such as Medidata Rave and Oracle InForm, IRT, eTMF, CTMS, and Microsoft Office Suite
• Ability to travel up to 40–60%, depending on project assignment and site geography
• 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
• Valid driver’s license
• Strong interpersonal and problem-solving skills
• Ability to work independently and within cross-functional teams
• Strong communication and organizational skills, attention to detail, and sense of urgency

• Full-time, permanent employment
• Home-based work arrangement
• Regular travel required
• Opportunity to mentor and support CRA I and II
• Participation in process improvement initiatives and development of best practices