Lead CRA

Key Responsibilities :

• Organizing and supervising clinical study :
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards / Ethics Committees / Research Ethics Committees, Clinical Operations (e.g. Contracts). Assist with resolving, identifying of problems including background and actions to prevent reoccurrences.
• Assist and conduct Clinical Monitoring activities as required
• Serve as key contact to assigned clinical sites throughout the study process Is accountable for achieving and reporting on agreed clinical milestones
• Supports study team in the interactions with Ethics Committees and Competent Authorities
• Participates actively to project team meetings, as required
• Close collaboration with internal stakeholders to ensure proper project conduct
• Assist in Providing site and Edwards personnel training including preparation / maintenance of study documents, completion of forms, understanding of examinations / assessments required
• Reporting site enrollment progress including device accountability and protocol deviations (inclusion / exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.
• Processing adverse events
• Document procedural case observations for insights in investigating post procedural events
• Data review, safety reporting and complaint handling
• Ensure regulatory and clinical protocol compliance is maintained, , including but not limited to :
• maintaining appropriate regulatory documents both internal and externally,
• adverse events and protocol deviations are reported in a timely manner,
• Ensure device complaints and malfunctions are reported.
• Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
• Develop new improved processes and perform implementation
• Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
• Ensures Audit readiness for internal, external and site Audits
• Acts as a mentor to new or junior level employees
• Other incidental duties as assigned by line management, leadership or by Clinical Trial Management

Education and Experience :

Additional Skills :