Senior Clinical Research Associate, Germany

🕒 September 17

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 11%

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Logo of Alimentiv

Alimentiv

201 - 500 employees

Founded 2020

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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