Senior Clinical Research Associate

Alira Health Group; Paris; Hybride; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A global clinical research organization is seeking a Senior Clinical Research Associate to oversee site monitoring for clinical trials. This role involves ensuring compliance and quality while collaborating with various team members. Candidates should possess a relevant BS degree and have experience in clinical monitoring. The position is remote and full-time, offering opportunities for professional growth and teamwork.

Qualifications

• 3 years in pharma/biotech/CRO industry with 2 years clinical monitoring.
• Ability to manage monitoring activities independently.
• Fluent in English and local language (for EU candidates).

Responsabilités

• Conduct site monitoring responsibilities for clinical trials.
• Ensure protocol compliance and address site questions.
• Manage study budgets and act as a referent for the sponsor.

Connaissances

Quality-focused

Detail-oriented

Strong organizational skills

Analytical skills

Negotiation skills

Leadership skills

Team skills

Formation

BS in Biology, Biotechnology, Life Sciences, or Pharmacy

Outils

Clinical trial systems

Electronic data capture

Description du poste

Senior Clinical Research Associate page is loaded

Senior Clinical Research Associate

Apply remote type Remote | time type Full time | posted on Posted 11 Days Ago | job requisition id JR000425

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. All contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

Job Description

Role

The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials, providing oversight, leadership, and guidance to ensure compliance and quality. The Sr CRA works closely with the US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Key Responsibilities

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed.
• Ensure appropriate and timely investigator site visits.
• Coordinate with cross-functional departments to facilitate negotiation and issue resolution related to clinical trial monitoring.
• Assist in developing study-specific Monitoring Plans and training presentations.
• Assist in setting up and collecting site-specific ethics documents and site contract negotiations.
• Provide monthly billing information to the finance team.
• Manage study budgets and act as a referent for the sponsor on monitoring stand-alone projects.
• Perform qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation.
• Prepare accurate and timely monitoring visit reports detailing site-related issues, resolutions, protocol deviations, study progress, and enrollment.
• Ensure data integrity through meticulous source document review and verification.
• Perform quality control and verification of documents collected at sites for eTMF/TMF.
• Conduct investigational product accountability.
• Review site regulatory binders for required documents.
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual, and respond to sponsor requests.
• Ensure compliance with ICH GCP guidelines, FDA regulations, and SOPs.
• Participate in internal, client/sponsor, scientific, and other meetings.
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.
• Work with in-house CRAs/CTC and data management to resolve data queries.
• Identify site issues proactively and develop problem-solving strategies.
• Prepare for audits at study sites as needed.
• Collaborate with other CRAs to maintain consistency and promote teamwork.
• Assist in CRA new hire training and onboarding.
• Mentor CRAs.
• Contribute to the development and maintenance of the Clinical Trial Management System (CTMS).
• Manage and resolve conflicting priorities to meet commitments.
• Perform additional duties as assigned.

Desired Qualifications & Experience

• US: BS/BA in life sciences or related field; 3 years in pharma/biotech/CRO industry; 2 years clinical monitoring; 1 year management experience.
• EU: Minimum 2 years clinical monitoring experience; ability to manage monitoring activities independently.

Technical Competencies & Soft Skills

• Quality-focused, careful, thorough, detail-oriented.
• Strong organizational skills; ability to multitask in a fast-paced environment.
• Manage priorities, organize time, solve problems.
• Strong analytical, negotiation, leadership, and team skills.
• Ability to travel and manage stress.
• Professional, trustworthy, disciplined.
• Problem-solve unstructured or ambiguous challenges.
• US: Fluent in English; EU: Fluent in local language and English.
• Excellent communication and interpersonal skills.
• Proficient with clinical trial systems and electronic data capture.
• Self-starter, collaborative, adaptable.
• Knowledge of clinical research, ICH GCP, local regulations.
• Ability to build positive relationships with sponsors, sites, and teams.
• US: Authorization to work in the U.S.; EU: Certified Monitor in Italy or relevant qualifications.

Languages

English
Education
BS in Biology, Biotechnology, Life Sciences, or Pharmacy
Contract Type
Regular