Biotecnologia ofertas em United States

Clinical Research Associate II / Sr. CRA, Spain

Rho, an award-winning, stable, full-service CRO based in the US, is expanding its presence in Europe. We provide comprehensive clinical development services and dedicated customer support worldwide.

Join us in redefining the CRO industry. At Rho, our team is passionate about healthcare and clinical research, driven by a shared goal to heal, cure, and address major health challenges.

We value passionate individuals working together to make a difference. As a Clinical Research Associate II / Sr. CRA, you will play a key role in ensuring the integrity and quality of our clinical trials, helping us navigate complex research landscapes and deliver healthcare solutions.

The Clinical Monitoring team at Rho is known for collaboration and excellence. Join us to advance your career and contribute to a culture of innovation, growth, and valued input.

This is a permanent, home-based CRA II / Senior CRA role in Spain.

Responsibilities

• Develop study tools, materials, and documentation for clinical trials.
• Mentor, train, and co-monitor junior CRAs and team members.
• Support the RFP process.
• Conduct onsite and remote monitoring visits across multiple protocols, including SQV, SIV, IMV, and COV, following GCP, protocol, and sponsor requirements.
• Document observations in reports and follow-up letters within required timelines.
• Maintain Investigator Site Files (ISF) and Trial Master Files (TMF).
• Assist with payment processes and review site and patient data for invoicing.
• Identify and report adverse events, serious adverse events, and pregnancies.
• Verify IMP handling and perform drug accountability.
• Participate in country and site feasibility assessments, site selection, and pre-study visits.
• Support vendor selection and assessments.
• Assist in negotiations and execution of site contracts.
• Prepare submission documents for ethics and regulatory authorities, communicating with involved parties.

For Senior CRAs

• Mentor, train, and co-monitor junior CRAs.
• Support Clinical Team Lead and Project Management tasks.
• Conduct sign-off visits and evaluate CRA competencies.
• Represent the team at meetings and conferences.
• Participate in CRA recruitment and interviews.
• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• Registered Nursing certification or equivalent, or relevant vocational qualification with at least 2 years of clinical monitoring experience.
• At least 2 years of on-site monitoring experience in CRO, pharma, or biotech industries.
• Fluent in English and the local language.
• Knowledge of ICH-GCP and local monitoring guidelines.
• Proven clinical monitoring skills and understanding of medical terminology and therapeutic areas.
• Willingness to travel approximately 80%, domestically and internationally.

Please submit your CV in English. Thank you!

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