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:

• Bachelor's Degree in a related field , 5 years experience of previous related medical device and/or clinical experience required or
• Associate's Degree or equivalent in a related field , 7 years experience of previous field monitoring experience, quality assurance/control and regulatory compliance required
• Mandatory: experience working in a medical device or regulated industry
• Experience with electronic data capture is necessary
• Other: Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred
• Other: Experience in interventional cardiology or cardiothoracic surgery preferred
• Other : Agile, dynamic, solution focused traits are preferred

Additional Skills:
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
• Excellent problem-solving and critical thinking skills
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control