Brio Group
Contract Clinical Research Associate (CRA) – Breast Cancer Subject Matter Expert
Contract Duration:
Multi-year contract
Location:
West Coast, with regional travel
Experience Required:
10+ years as a CRA; 3+ years in breast cancer clinical trials
Overview We are seeking a highly experienced Contract Clinical Research Associate with deep expertise in breast cancer clinical trials. This role supports key Phase I–III oncology programs and requires a seasoned CRA who can independently oversee complex sites and serve as the breast cancer SME for the study team.
Key Responsibilities
Serve as the breast cancer SME, advising on protocol execution, site engagement, and clinical considerations across assigned studies.
Conduct onsite and remote monitoring visits to ensure adherence to GCP, protocols, and SOPs.
Assess site performance, verify data accuracy, and ensure timely completion of queries and documentation.
Support site start-up, activation, enrollment oversight, and close-out activities.
Proactively identify risks at the site level and implement corrective and preventive actions.
Partner closely with cross-functional teams, investigators, and site staff to drive high-quality trial execution.
Provide guidance or informal mentoring to junior CRAs when needed.
Qualifications
10+ years of CRA experience, including 3+ years specifically in breast cancer studies.
Strong understanding of solid tumor oncology endpoints, safety reporting, and breast cancer treatment standards.
Proven success managing high-enrolling or complex oncology sites.
Excellent communication, documentation, and relationship-building skills.
Based on the West Coast, with ability to travel regionally (approx. 50–70%).
Bachelor’s degree in a life science field (advanced degree a plus).
Ideal Candidate
Confident serving as the primary resource for breast cancer–specific protocol and clinical insights.
Highly independent, organized, and solution-oriented.
Comfortable working with both sponsor and CRO environments.
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Multi-year contract
Location:
West Coast, with regional travel
Experience Required:
10+ years as a CRA; 3+ years in breast cancer clinical trials
Overview We are seeking a highly experienced Contract Clinical Research Associate with deep expertise in breast cancer clinical trials. This role supports key Phase I–III oncology programs and requires a seasoned CRA who can independently oversee complex sites and serve as the breast cancer SME for the study team.
Key Responsibilities
Serve as the breast cancer SME, advising on protocol execution, site engagement, and clinical considerations across assigned studies.
Conduct onsite and remote monitoring visits to ensure adherence to GCP, protocols, and SOPs.
Assess site performance, verify data accuracy, and ensure timely completion of queries and documentation.
Support site start-up, activation, enrollment oversight, and close-out activities.
Proactively identify risks at the site level and implement corrective and preventive actions.
Partner closely with cross-functional teams, investigators, and site staff to drive high-quality trial execution.
Provide guidance or informal mentoring to junior CRAs when needed.
Qualifications
10+ years of CRA experience, including 3+ years specifically in breast cancer studies.
Strong understanding of solid tumor oncology endpoints, safety reporting, and breast cancer treatment standards.
Proven success managing high-enrolling or complex oncology sites.
Excellent communication, documentation, and relationship-building skills.
Based on the West Coast, with ability to travel regionally (approx. 50–70%).
Bachelor’s degree in a life science field (advanced degree a plus).
Ideal Candidate
Confident serving as the primary resource for breast cancer–specific protocol and clinical insights.
Highly independent, organized, and solution-oriented.
Comfortable working with both sponsor and CRO environments.
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