Job Description

Job Description

Job Description

The Senior Clinical Research Associate (Sr. CRA) oversees complex site activities and mentors junior CRAs, providing expertise and guidance across clinical studies. This role includes advanced responsibilities in site management, monitoring quality, and developing site-specific study materials. The Sr. CRA ensures regulatory compliance and process improvements, contributing to the successful conduct of clinical trials. This is a remote role with site travel as needed.

Title(s): Senior Clinical Research Associate

Job Family : Clinical Research Associate

Location : This is a home-based position.

Responsibilities :

• Manage site monitoring activities for complex studies, ensuring high-quality deliverables and regulatory compliance.
• Mentor junior CRAs, providing support in site management practices and best practices.
• Assist in the development and review of study plans, forms, tools, and site training materials.
• Prepare detailed monitoring reports and documentation with minimal oversight.
• Collaborate with study teams, offering strategic insights to improve processes and enhance study efficiency.
• Facilitate audit preparations, monitor data quality, and address protocol deviations.
• Serve as an advanced resource for clinical study management, guiding the team on critical issues.

Qualifications:

Required Qualifications:

• Education: Bachelor’s degree in life sciences, biomedical sciences, or a related field with in-depth knowledge of oncology terminology and clinical practices.
• Experience: Minimum of 5 years in clinical research monitoring, with at least 1 year of CRA experience at LumaBridge preferred.
• Leadership: Proven experience in mentoring and supporting junior CRAs.
• Regulatory Knowledge: Advanced knowledge of ICH-GCP, FDA regulations, and clinical study standards.
• Communication Skills: Exceptional written and verbal communication skills, with the ability to present complex concepts clearly.
• Technical Proficiency: Advanced proficiency in Microsoft Office Suite, EDC, and CTMS applications.

Preferred Qualifications:

• Oncology Expertise: Early-phase oncology experience preferred.
• Process Improvement: Experience in identifying and implementing process improvements within clinical monitoring.
• Audit Management: Familiarity with audit processes, preparation, and follow-up activities.

We are an equal-opportunity employer and are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by law. We celebrate diversity and are dedicated to creating an environment of mutual respect, encouraging employees from all backgrounds to apply.

We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in our hiring processes and in all aspects of employment. If you require accommodation to participate in the application or interview process, please let us know by contacting our Human Resources department ( hrapplicants@lumabridge.com ). We will work with you to provide necessary adjustments to ensure a fair and accessible hiring experience.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

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