Clinical Research Associate

Há 13 horas

São Paulo, State of São Paulo, Brasil SoTalent Tempo integral

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Job Title: Oncology Clinical Research Associate (CRA II)

Location:
Paraíso, São Paulo (Hybrid/Field-Based) Sector: Clinical Research – Biotech Specialist CRO About the Client: I am currently partnering with a globally recognized, specialized Clinical Research Organization (CRO) that focuses exclusively on supporting the unique needs of the biotechnology sector. With a reputation for agility and a deep therapeutic focus, my client is looking to expand its monitoring team in Brazil to support high-impact oncology trials. The Role: As a CRA II, you will serve as the primary point of contact for clinical sites, ensuring the highest standards of data integrity and patient safety. This is a role for a monitoring professional who thrives in a fast-paced environment and is passionate about bringing innovative cancer treatments to market. Primary

Responsibilities:
Manage the full lifecycle of site visits, including pre-study/selection, initiation, routine monitoring, and close-out, ensuring adherence to ICH-GCP and study protocols. Partner with investigative sites to develop and implement effective patient recruitment and retention strategies. Provide ongoing training to site staff regarding specific protocols and regulatory expectations. Perform rigorous source data verification (SDV) and monitor the accuracy of Case Report Forms (CRFs). Oversee the maintenance of the Trial Master File (TMF) and Investigator Site Files (ISF). Identify and escalate quality issues or site performance trends to project leadership. Manage site-level administrative duties, potentially including budget tracking and regulatory document collection.

Requirements:

Education:
Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.

Experience:
A minimum of 1 year of independent, on-site monitoring experience. Therapeutic Expertise: Proven experience monitoring Oncology trials is essential. Knowledge: Deep understanding of local Brazilian regulatory requirements, GCP, and ICH guidelines. Mobility: Willingness to travel to sites as required by the study protocol. Language: Professional proficiency in English and Portuguese (written and verbal) is expected. Why Join This Team? This is an opportunity to work within a dedicated biotech-focused environment where your expertise in oncology will be directly applied to breakthrough research. My client offers a collaborative culture and the chance to work on complex, high-science protocols.

How to Apply
If you are an experienced CRA looking to specialize further in the oncology space with a leading global partner, please submit your CV for a confidential discussion.

Clinical Research Associate

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