Senior Clinical Research Associate

🕒 September 24

🇪🇸 Spain – Remote

💵 €45k - €60k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 for clinical trials independently • Provide oversight, leadership, and guidance in the management and execution of clinical trials • Ensure protocol compliance and quality • Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets • 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 and training presentations • Assist with ethics documents and site contract negotiation • Provide monthly billing information to finance • Manage study budgets and act as sponsor referent for stand-alone projects • Perform qualification, initiation, interim, and close-out visits remotely and onsite • Prepare monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment • Review source documents and verify CRF data integrity • Perform quality control and document verification for eTMF/TMF • Conduct investigational product accountability • Review site regulatory binders • Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests • Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs • Participate in internal, client/sponsor, scientific, and other meetings • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs • Resolve discrepant data queries with CRAs/CTC and data management • Identify site issues and develop problem-solving strategies • Conduct audit preparation at study sites • Assist with CRA training and onboarding • Mentor CRAs • Collaborate on Clinical Trial Management System (CTMS) development and maintenance • Manage conflicting priorities and deliver on commitments • Perform additional assigned duties

🎯 Requirements

• Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities • Oncology experience • Availability to travel • Quality focused; Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Able to manage priorities, organize time and solve problems • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Ability to travel • Ability to manage stress • Professional, trustworthy and disciplined • Ability to problem-solve unstructured or ambiguous challenges • Strong command of Local language, both written and verbal, in the country where monitoring activities are performed • Excellent communication and interpersonal skills with customer service orientation • Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture • Self-starter who thrives in a collaborative, yet less structured team environment • Knowledge of clinical research, ICH GCP and local regulations • Knowledge of Regulatory and Ethical requirements • Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members • Graduation in a scientific health field • Adequate English • Bachelor of Science (BS) in Biology, Biotechnology, Life Sciences, or Pharmacy