Clinical Research Associate; Oncology Monitoring Experience Required

Alira Health Group; Catania; Remoto; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A global health advisory firm is seeking a Clinical Research Associate with oncology monitoring experience. This role involves conducting site monitoring for clinical trials and ensuring compliance with regulations. The ideal candidate will possess strong analytical and organizational skills, and a Bachelor’s degree in a relevant field. This position allows for remote work and full-time engagement.

Servizi

Professional development

Flexible work

Global travel

Competenze

• At least 2+ years of oncology monitoring experience.
• Graduation in a scientific health field with certification in Italy.
• Ability to manage monitoring activities independently.

Mansioni

• Conduct site monitoring responsibilities for clinical trials.
• Ensure compliance and quality in clinical trial operations.
• Assist with study recruitment and site training.

Conoscenze

Oncology monitoring experience

Strong analytical skills

Organizational skills

Communication skills

Formazione

Bachelor of Science in Biology or Life Sciences

Descrizione del lavoro

Clinical Research Associate; Oncology Monitoring Experience Required

Apply remote type: Remote locations: Boston-Remote, Americas-Remote, time type: Full time, posted on: Posted 2 Days Ago, job requisition id: JR000420

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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

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

Job Responsibilities

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budgets.
• Review monitoring visit reports, 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 reference 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, documenting 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.
• Comply 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 discrepancies.
• Proactively identify site issues and develop problem-solving strategies.
• Conduct audit preparation at study sites.
• Collaborate with team members to maintain consistency and promote a collaborative atmosphere.
• Participate in training and onboarding of new CRAs.
• Perform CRA mentoring.
• Manage and resolve conflicting priorities to meet commitments.
• Perform additional duties as assigned.

Qualifications & Experience

• At least 2+ years of oncology monitoring experience.
• EU: Graduation in a scientific health field; Certified Monitor in Italy per the CRO decree of 15 Nov 2011.
• Ability to establish and maintain positive relationships with sponsors, sites, and project teams.
• Ability to manage monitoring activities independently.

Technical Skills & Soft Skills

• Detail-oriented, thorough, and quality-focused.
• Strong organizational, multi-tasking, and problem-solving skills.
• Ability to manage priorities, organize time, and handle stress.
• Strong analytical, negotiation, leadership, and communication skills.
• Willingness and ability to travel.
• Professional, trustworthy, and disciplined.
• Knowledge of clinical research, ICH GCP, local regulations, and regulatory/ethical requirements.
• Proficiency in English and local language (where monitoring occurs).

Education

Bachelor of Science (BS) in Biology or Life Sciences.

Contract Type

Regular

About Us

Alira Health is a global advisory firm providing consulting, research, and clinical development services, aiming to humanize healthcare and life sciences through innovative technologies and expert guidance.

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With offices worldwide, we offer a vibrant environment with benefits including professional development, global travel, flexible work, and more. We value passion, talent, entrepreneurial spirit, and teamwork.

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