Sr. Clinical Research Associate
Core
Ensuring the integrity, quality, and compliance of clinical trials for transplant patients through site monitoring and data management.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial execution and data accuracy for transplant patient care solutions
Domain
Biotech/Pharma, Clinical Research, Transplant Medicine
Deliverable
client delivery
Required skills
Clinical study management, GCP/FDA/ISO regulatory knowledge, EDC systems proficiency, data reconciliation, site recruitment oversight, protocol development, SOP creation, stakeholder communication
Preferred skills
CCRC or CCRA certification, experience in biotech/pharma/medical device/academia, clinical programming expertise
Technologies
EDC systems, CTMS, Microsoft Office Suite
Responsibilities
Conduct site visits (selection, initiation, interim, close-out) to ensure protocol adherence and patient safety; Collaborate with Principal Investigators and study coordinators to drive study success; Ensure compliance with ICH/GCP, IRB requirements, and internal monitoring plans; Identify and resolve data collection issues within EDC systems; Review and reconcile data queries, listings, and discrepancies; Maintain accurate and complete study documentation and files; Lead study team meetings and contribute to protocol development and amendments; Support site recruitment and provide oversight to ensure enrollment goals are met; Mentor junior CRAs and provide technical expertise in clinical programming and data validation; Assist in the development and refinement of SOPs, workflows, and templates; Partner with Clinical Trials Manager to manage timelines, budgets, and resources; Liaise with regulatory authorities and CROs as needed; Ensure timely and compliant execution of monitoring reports, trip reports, and follow-up letters; Monitor site performance metrics and facilitate effective communication across stakeholders
Seniority
Senior, hands-on IC
