Senior Clinical Research Associate, Romania

🔥 0 minutes ago

🇷🇴 Romania – Remote

💵 lei200k - lei250k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 standard processes, ICH/GCP guidelines and local regulation • 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 study data against source documents and resolve or escalate data queries • Coordinate shipment and delivery of clinical supplies and study documents • Train site staff on protocols, study plans, systems and ICH-GCP • Manage site activation, recruitment milestones, site issues, action items and protocol deviations • Review ISF, TMF and study systems for accuracy, timeliness and completeness • Participate in investigator meetings, study meetings, audits and inspections • Perform CRA Assessment Visits and co-monitoring visits • Support hiring interviews, process improvements and best-practice development

🎯 Requirements

• 4 - 6 years of related experience • (Honors) Bachelor’s degree • Fluent in written and verbal English • Or an equivalent combination of education and experience may be considered • Thorough knowledge of ICH-GCP and local regulatory requirements • Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel up to 40-60%, depending on project assignment and geographic location of sites • Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams • Great communication and organizational skills, detailed orientation and sense of urgency • Holder of a valid driver’s license • 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

🏖️ Benefits

• Annual Bonus (Short Term Incentive Program) target = 8% of annual salary • A monthly stipend of 400 RON (pro-rated based on hours of work) to offset business use of communication costs (internet, VoIP, land line, etc.) • Monthly Cell phone stipend (RON 50) • One time expense reimbursement of up to 500.00 (local currency) to purchase office items such as a scanner/printer, extra monitor, office furniture and supplies • Mileage reimbursement for travel • Home-based work arrangement