Clinical Research Associate; Oncology Monitoring Experience Required

Alira Health Group; Como; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global advisory firm is seeking a Clinical Research Associate with at least 2 years of oncology monitoring experience. You will ensure compliance and quality in clinical trials, conduct site visits, and manage study budgets. The ideal candidate has a Bachelor’s degree in a relevant field and strong communication skills. This remote role offers a vibrant working environment with benefits including professional development and flexibility.

Servizi

Professional development

Global travel

Flexible work

Competenze

• At least 2 years of oncology monitoring experience.
• Ability to manage monitoring activities independently.
• Ability to establish positive relationships with sponsors, sites, and teams.

Mansioni

• Provide guidance and oversight to ensure adherence to project scope.
• Conduct qualification, initiation, interim, and close-out visits.
• Review monitoring visit reports and ensure compliance.

Conoscenze

Oncology monitoring

Strong organizational skills

Analytical skills

Excellent communication

Negotiation skills

Formazione

Bachelor of Science in Biology or Life Sciences

Certified Monitor in Italy

Strumenti

Clinical trial systems

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

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Our shared values are: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

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

Job Responsibilities

1. Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budgets.
2. Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed.
3. Ensure timely investigator site visits.
4. Coordinate with cross-functional departments to resolve monitoring issues.
5. Assist in developing Monitoring Plans and training materials.
6. Support site document collection and negotiation of site contracts.
7. Manage study budgets and act as a liaison for sponsors.
8. Perform qualification, initiation, interim, and close-out visits, ensuring proper documentation.
9. Prepare accurate monitoring visit reports.
10. Review source documents for data integrity.
11. Verify documents for eTMF/TMF.
12. Conduct investigational product accountability.
13. Review site regulatory binders.
14. Maintain contact with sites to ensure compliance and monitor patient accrual.
15. Ensure compliance with ICH GCP, FDA regulations, and SOPs.
16. Participate in meetings and facilitate adverse event reporting.
17. Collaborate with data management to resolve data discrepancies.
18. Identify site issues and develop solutions.
19. Prepare for audits at study sites.
20. Support CRA training and onboarding.
21. Mentor new CRAs.
22. Manage and resolve conflicting priorities.
23. 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.
• Ability to establish positive relationships with sponsors, sites, and teams.
• Ability to manage monitoring activities independently.

Technical Skills & Soft Skills

• Detail-oriented with strong organizational skills.
• Ability to multi-task and work effectively in fast-paced environments.
• Strong analytical, negotiation, and leadership skills.
• Ability to travel and manage stress.
• Professional, trustworthy, and disciplined.
• Problem-solving skills for unstructured challenges.
• Excellent communication in local language and English.
• Proficiency with clinical trial systems and databases.
• Knowledge of ICH GCP, local regulations, and ethical requirements.

Education

Bachelor of Science in Biology or Life Sciences.

Contract Type

Regular

About Us

Alira Health is a global advisory firm dedicated to humanizing healthcare and life sciences through innovative technologies and expert guidance, partnering with patients and clients across the lifecycle of development and medical care.

Why Work at Alira Health?

We offer a vibrant, creative environment with benefits including professional development, global travel, flexible work, and more. Join our diverse team of over 800 professionals from 30+ nationalities, committed to delivering innovative solutions and improving patient care.

Join Our Team

Apply to our open positions or send a spontaneous application. We look forward to your contribution!