Sr. CRA 1, Brazil

IQVIA LLC; São Paulo; Presencial; BRL 90 000 - 130 000; Tempo integral

Resumo da oferta

IQVIA Biotech is seeking a Sr. CRA 1 in Brazil to perform site monitoring and site management activities, ensuring studies are conducted per protocol and regulatory guidelines.

The role emphasizes collaboration with sites to manage recruitment plans and regulatory submissions while maintaining data quality. Ideal candidates will have a Bachelor's degree in a scientific field or healthcare and 3–4 years of on-site monitoring experience, with strong knowledge of GCP and regulatory requirements.

Qualificações

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 3-4 years of on-site monitoring experience.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with the scope of work and GCP.
• Work with sites to adapt and track subject recruitment plan to enhance predictability.
• Administer protocol training and maintain regular communication with sites to manage project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues as needed.
• Manage progress of studies by tracking regulatory submissions, recruitment, CRF completion, data queries, and resolution.

Conhecimentos

On-site monitoring

Regulatory knowledge

Communication skills

Formação académica

Bachelor's degree in science or health care

Descrição da oferta de emprego

IQVIA Biotech is now hiring for Sr. CRA 1 location Brazil, oncology preferred. IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Job Profile Summary

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Job Functions, Duties and Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Responsibilities Essential Functions

• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 3-4 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.