Senior Clinical Research Associate, Serbia

🔥 14 hours ago

🇷🇸 Serbia – 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 conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Serbia and Croatia • Ensure investigative sites comply with protocols, ICH-GCP, applicable regulations, SOPs and project requirements • Act as primary contact for assigned sites and resolve questions, issues, action items and protocol deviations • Review clinical trial data, source documentation and study systems for accuracy, completeness, data integrity and compliance • Support site selection, activation, recruitment, study milestones and patient recruitment targets • Train sites on protocols, study systems, processes and applicable requirements • Maintain essential study documentation, including ISF and TMF • Collaborate with sponsors, project teams, vendors and investigative sites • Participate in audits, inspections, Investigator Meetings, study meetings and other project activities • Mentor CRA I and II colleagues, participate in co-monitoring and CRA assessments, and contribute to process improvement

🎯 Requirements

• Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline • 4–6 years of relevant clinical research experience • Strong clinical site monitoring experience from site start-up through close-out • Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements • Proficiency with EDC, IRT, eTMF, CTMS and Microsoft Office • Strong understanding of site management, including site activation, recruitment, training, issue resolution and essential documentation • Excellent communication, interpersonal and relationship-management skills • Strong organisational, problem-solving and prioritisation skills • Ability to work independently, exercise sound judgement and manage competing priorities • Willingness and ability to travel approximately 40–60% • Valid driver’s licence required • Fluent written and verbal English • Experience with Phase I–IV clinical trials, Medidata Rave or Oracle InForm, and mentoring junior CRAs preferred

🏖️ Benefits

• Education Reimbursement program for full-time employees • Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) • One time office setup allowance for a scanner/printer, extra monitor, office furniture, etc. • Working while visiting program – up to 4 weeks per year • Flexible Summer Hours Program from May – September • Employee referral incentive • Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after 5 years of employment • Optional formal mentorship program (Alimentorship) • Country/region annual social events in person • Leadership development programs for people leaders in accordance with seniority • Social committee and other optional initiatives • Additional benefits may be available depending on country of employment and local policies and eligibility

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