Clinical Research Associate (CRA) - Remote
About the Opportunity:
LumaBridge is seeking an experienced Clinical Research Associate (CRA) to join our team. The CRA will serve as the primary liaison between Investigator sites and LumaBridge, overseeing site conduct and fostering key relationships with site personnel. This role is essential in advancing the development of oncology therapies and technologies that improve patients' lives. The CRA will work independently in a highly visible and collaborative environment, ensuring clinical trials are executed in accordance with regulatory requirements and internal standards.
Job Titles:
Clinical Research Associate
Senior Clinical Research Associate (Sr. CRA)
Principal Clinical Research Associate (Principal CRA)
Location:
Remote-based, with occasional site travel (<50% based on business needs). Sites may be located anywhere within the continental United States.
Key Responsibilities:
Site Management: Perform site selection, initiation, monitoring, and close-out visits for LumaBridge’s clinical trials.
Monitoring Activities: Track patient recruitment, CRF completion, source data verification, data collection, and query resolution.
Investigational Product Management: Ensure Investigational Product (IP) accountability, lab/kit supply management, and PI oversight of all trial activities.
Collaboration: Develop and maintain collaborative relationships with investigative sites, ensuring compliance, enrollment, and understanding of study requirements.
Documentation and Reporting: Write and submit accurate visit letters and reports, updating the CTMS. Ensure essential documentation is reviewed and reconciled.
Protocol Compliance: Address protocol deviations and data quality issues, identifying improvements for assigned sites.
Study Team Contribution: Actively contribute to the study team by providing insights, updates, and strategies to improve processes.
Additional Duties: Assist with CRF development, user access testing, and other duties as assigned.
Responsibilities by Role:
Senior CRA (Sr. CRA):
Mentor junior or entry-level CRAs.
Assist in the development and review of study plans, tools, and site training materials.
Develop letters, reports, and documents with minimal revision.
Principal CRA (Principal CRA):
Review monitoring visit reports.
Expert in developing documents and reports with minimal oversight.
Serve as a Subject Matter Expert (SME).
Stay updated on industry standards and apply them across LumaBridge.
Qualifications:
Education: Bachelor’s degree in life science, biomedical, or medical science with proficiency in clinical/scientific terminology, especially in oncology.
Experience:
CRA: 2+ years of clinical research experience, including field monitoring of oncology trials.
CRO/Sponsor Experience: 2+ years required.
Oncology: Early phase oncology experience preferred.
Monitoring Experience: Experience in independent field monitoring of oncology clinical trials.
Regulatory Knowledge: Strong understanding of ICH-GCP and regulatory requirements.
Skills:
Excellent communication skills (written and verbal).
Effective presentation skills for explaining complex concepts.
Strong time management and organizational skills.
Proficient in Microsoft Office, EDC, and CTMS applications.
Fluency in English (written and verbal).
Ability to travel (<50%) with necessary qualifications for independent site regulations (including vaccinations).
Role-Specific Experience:
Sr. CRA: 5+ years of monitoring experience, with at least 1 year of CRA experience at LumaBridge preferred.
Principal CRA: 8+ years of monitoring experience, with at least 2 years of Sr. CRA experience at LumaBridge preferred.
LumaBridge offers an exciting and dynamic environment where CRAs can develop professionally while advancing groundbreaking oncology therapies. If you're passionate about clinical research and making a difference in oncology, apply today!
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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