Meet Life Sciences · 9 hours ago
Senior Clinical Research Associate
Meet Life Sciences is partnering with a global biopharmaceutical company advancing an innovative oncology pipeline. They are seeking an experienced Senior Clinical Research Associate (Senior CRA) to take a lead role in the execution of early-phase oncology studies, ensuring compliance and overseeing patient safety and data integrity.
Responsibilities
Lead site monitoring activities for Phase I oncology trials, including SIVs, IMVs, and COVs
Act as a primary point of contact for assigned sites, driving performance, quality, and timelines
Ensure compliance with ICH-GCP, SOPs, and FDA regulations
Oversee patient safety, protocol adherence, and data integrity at site level
Mentor junior CRAs and provide input into monitoring strategy and best practices
Support site feasibility, selection, initiation, and inspection readiness
Identify, escalate, and proactively mitigate site and study risks
Collaborate closely with Clinical Operations, Medical, Data Management, and external partners
Qualification
Required
Bachelor's degree in Life Sciences or a related discipline
4+ years of CRA experience, with a strong background in oncology clinical trials
Proven experience supporting Phase I / early-phase studies (FIH experience highly desirable)
Strong working knowledge of ICH-GCP and US regulatory requirements
Experience monitoring US sites independently
Excellent communication, leadership, and organisational skills
Willingness to travel as required
Company
Meet Life Sciences
Life Sciences Affects Us All.
Funding
Current Stage
Growth StageRecent News
2024-05-29
2024-04-26
2024-01-31
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