**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.