Senior Clinical Research Associate, Poland

🕒 Yesterday

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Manage, deliver and/or perform full clinical site monitoring services for one or more clinical trial projects • Design and oversee project monitoring services, including training, site/patient recruitment, site data/document management, project site budgets, and regulatory filings • Conduct and document onsite and remote site monitoring, qualification, initiation, and close-out visits • Verify 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 • Act as primary contact for investigational sites and liaison between CRAs and the project team • Oversee study integrity, site compliance, action items, protocol deviations, and regulatory issues • Review ISF, TMF, and study-related systems for accuracy, timeliness, and completeness • Support site activation, patient recruitment, study timelines, regulatory review, localization, and translation of site documents • Participate in audits, inspections, study meetings, teleconferences, and Investigator meetings • Mentor CRA I and II, perform assessment or co-monitoring visits, and provide feedback • Participate in CRA interviews, process improvement initiatives, and best-practice development • Maintain collaborative relationships with stakeholders

🎯 Requirements

• Minimum of a college diploma/degree • 4–6 years of related experience • Strong communication, interpersonal, organizational, and problem-solving skills • Self-motivation, critical thinking, attention to detail, and ability to work independently and within cross-functional teams • Ability to regularly travel to study sites approximately 5–8+ days per month • 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, IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel up to 40–60%, depending on project assignment and site geography • Great communication and organizational skills, detailed orientation, and sense of urgency required