Senior Clinical Research Associate

🕒 October 14

🇪🇸 Spain – Remote

💵 €45k - €60k / 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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Alira Health

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $58M Venture Round on 2023-01

Healthcare • Manufacturing • Healthcare Insurance

Alira Health is a global consulting firm that partners with life sciences companies to develop innovative solutions in healthcare. The company specializes in a wide range of services including research and clinical development, regulatory compliance, and management consulting. Alira Health focuses on patient engagement, market access, and providing real-world solutions to improve patient outcomes. They are committed to environmental sustainability and actively participate in community involvement and ESG initiatives. Alira Health also provides technology solutions with a focus on improving life sciences research through empathy and scientific excellence.

📋 Description

• Conduct site monitoring responsibilities independently for clinical trials • Provide oversight, leadership, and guidance in the management and execution of clinical trials • Guide, oversee, and provide feedback to CRA team members • Review monitoring visit reports and conduct co-monitoring and evaluation visits • Ensure timely investigator site visits • Coordinate cross-functional departments to resolve clinical trial monitoring issues • Assist with monitoring plans, training presentations, ethics documents, and site contract negotiations • Provide monthly billing information and manage study budgets for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare accurate monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control and verification of eTMF/TMF documents • Conduct investigational product accountability and review site regulatory binders • Maintain contact with study sites to ensure protocol and GCP compliance • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with in-house CRAs, CTC, and data management • Identify site issues and develop problem-solving strategies • Prepare study sites for audits • Participate in internal, client/sponsor, scientific, and other meetings • Assist with CRA training and onboarding; mentor CRAs • Collaborate on the development and maintenance of the CTMS • Manage conflicting priorities and perform additional assigned duties

🎯 Requirements

• Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry • Ability to autonomously manage monitoring activities • Availability to travel in Spain • Oncology experience required • Strong command of the local language, written and verbal, in the country where monitoring activities are performed • Adequate English • Graduation in a scientific health field • Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy • Quality-focused, careful, thorough, and detail-oriented • Strong organizational skills and ability to multitask in a fast-paced environment • Ability to manage priorities, organize time, and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to manage stress and solve unstructured or ambiguous challenges • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture • Knowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical requirements • Ability to establish and maintain positive relationships with sponsors, sites, and project team members

🏖️ Benefits

• Remote work arrangement • Opportunities for collaboration across global teams and time zones • Regular travel in Spain • Professional development through CRA new hire training, onboarding, and mentoring