Clinical Research Associate
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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.
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