Senior Clinical Research Associate

🔥 31 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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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 conduct and document onsite and remote site management activities, including site qualification, initiation, monitoring and close-out visits • Serve as a primary point of contact for investigative sites • Follow site questions, issues, action items and protocol deviations through to resolution • Review source documentation and study systems for accurate, complete and compliant clinical data • Manage and facilitate resolution of data queries • Oversee site activation and ongoing site management activities • Work with sites and cross-functional teams to achieve project timelines, milestones and recruitment objectives • Ensure site personnel are trained on study protocols, plans, systems, ICH-GCP requirements and project-specific expectations • Review Investigator Site Files, Trial Master Files and study systems for accuracy, completeness, timeliness and compliance • Coordinate site-related activities and communications, including clinical supplies, investigational product, laboratory materials, ePROs, study documentation and project updates • Collaborate with Study Start-up, Regulatory and other cross-functional teams • Support document collection, localisation and translation activities where required • Participate in study meetings, Investigator Meetings, audits and inspections • Support issue resolution and implementation of corrective actions • Mentor and support CRA I and CRA II colleagues, including CRA Assessment Visits, co-monitoring and sign-off activities • Contribute to CRA interviews, training and process improvement initiatives

🎯 Requirements

• (Honours) Bachelor’s degree required; a degree in Health Sciences, Life Sciences, Pharmacy or Nursing is preferred • Minimum 4–6 years of relevant clinical research experience • Thorough knowledge of ICH-GCP and applicable local regulatory requirements • Demonstrated experience independently conducting site qualification, initiation, monitoring and close-out visits • Proficiency with clinical trial systems including EDC platforms such as Medidata Rave and Oracle InForm, IRT, eTMF and CTMS, as well as Microsoft Office • Strong interpersonal, communication and problem-solving skills • Ability to work independently and effectively within cross-functional teams • Strong organisational skills and attention to detail • Ability to manage priorities with an appropriate sense of urgency • Fluent written and verbal English • An equivalent combination of education and relevant experience may be considered • Valid driver’s licence • Ability to travel approximately 40–60%, depending on project assignment and geographic location of investigative sites

🏖️ Benefits

• Education Reimbursement program for full-time employees • Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) • One time office setup allowance (can be used to purchase 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 several other optional initiatives • Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility

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