Senior Clinical Research Associate, Germany

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

📋 Description

• Independently manage, coordinate, and supervise clinical site monitoring services.

• Evaluate protocol and regulatory adherence in accordance with company and sponsor procedures, ICH/GCP standards, and local regulations.

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

• Implement clinical study plans effectively.

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

• Analyze study data against source documents and address or elevate data queries as necessary.

• Organize the shipment and delivery of investigational products, lab supplies, ePROs, and study documentation.

• Educate site personnel on protocols, study plans, systems, and ICH-GCP guidelines.

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

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

• Facilitate site activation, recruitment milestones, study communications, and project timelines.

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

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

• Assist in hiring interviews and initiatives for process improvement.

⛳️ Requirements

• 4–6 years of relevant experience.

• Bachelor’s degree (Honors preferred).

• Proficiency in written and spoken English.

• An equivalent combination of education and experience may be acceptable.

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

• Skilled in using EDC systems such as Medidata Rave and Oracle InForm, IRT, eTMF, CTMS, and Microsoft Office Suite.

• Willingness to travel up to 40–60%, depending on project assignments and site locations.

• Degree in Health Sciences, Life Sciences, Pharmacy, or Nursing is preferred, or hold a Sr. CRA and/or ACRP Certification/Designation.

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

• Possession of a valid driver’s license.

• Excellent interpersonal and problem-solving abilities.

• Capability to work both independently and as part of cross-functional teams.

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

🏝️ Benefits

• Full-time, permanent employment.

• Flexible home-based work arrangement.

• Regular travel is required.

• Opportunity to mentor and assist CRA I and II.

• Involvement in process improvement initiatives and the development of best practices.