Clinical Research Associate

SoTalent; São Paulo; On-site; BRL 120,000 - 180,000; Full time

Job summary

Sotalent in Brazil seeks an Oncology Clinical Research Associate (CRA II) to act as the primary site contact, ensuring data integrity and patient safety in high-impact oncology trials. You will monitor sites, ensure ICH-GCP compliance, and support study teams in a fast-paced biotech CRO environment.

Requirements include a Life Sciences degree, at least 1 year of independent on-site monitoring, Oncology experience, and proficiency in English and Portuguese. Travel to sites will be required.

Qualifications

• Bachelor-level life sciences or healthcare degree required.
• Minimum 1 year of independent, on-site monitoring experience.
• Experience monitoring oncology trials is essential.

Responsibilities

• Manage full lifecycle of site visits: pre-study, initiation, routine monitoring, close-out.
• Collaborate with investigative sites to implement patient recruitment and retention strategies.
• Provide ongoing training to site staff on protocols and regulatory expectations.
• Perform source data verification (SDV) and ensure accuracy of CRFs.
• Maintain Trial Master File (TMF) and Investigator Site Files (ISF).
• Flag quality issues or site performance trends to project leadership.

Skills

Oncology monitoring

GCP/ICH knowledge

English proficiency

Portuguese proficiency

Education

Bachelor's degree in Life Sciences or related field

Job description

Job Title

Oncology Clinical Research Associate (CRA II)

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 elevate 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.