Senior Clinical Research Associate

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Alimentiv

WebsiteLinkedInAll Job Openings

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 • Provide guidance and mentoring to CRA I and II • Conduct and document onsite and remote monitoring, close-out, qualification, and initiation visits • Review source documents, study data, ISF, TMF, EDC, and other study systems for accuracy, completeness, and compliance • Monitor and resolve data queries, site issues, action items, and protocol deviations • Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents • Train site staff on protocols, study plans, systems, and ICH-GCP • Participate in study meetings, teleconferences, Investigator meetings, audits, and inspections • Support site selection, activation, patient recruitment, and achievement of project timelines and milestones • Review, localize, translate, and file site documents as required • Perform CRA assessment and co-monitoring visits and provide feedback • Participate in CRA interviews, process improvements, and best-practice initiatives

🎯 Requirements

• Minimum college diploma/degree and 4–6 years of related experience • 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 • Proficiency with EDC systems such as Medidata Rave and Oracle InForm • Proficiency with IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel 40–60%, depending on project assignment and site geography • 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 • Self-motivation and commitment to achieving positive results • Commitment to continuous learning, self-development, and teamwork

🏖️ Benefits

• One-time sign-on bonus of approximately 15,225 RON • Annual bonus target of 8% of annual salary • Monthly communication-cost stipend of 400 RON • Monthly cell phone stipend of 50 RON • One-time reimbursement of up to 500 local currency for office equipment and supplies • Mileage reimbursement for travel