Lead CRA

Job content

Responsible for remotely supporting field clinical research associate/ site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities

• Organizing and supervising clinical study:
• Assist and conduct Clinical Monitoring activities
• 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
• Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements
• Develop new improved processes and perform implementation
• Ensures Audit readiness for internal, external and site Audits
• Act as a mentor to new or junior level employees
• Other incidental duties as assigned by management
  

Education And Experience

Bachelor’s Degree or equivalent in in related field , 5 years years experience of previous related medical device and/or clinical experience Required or

Associate’s Degree or equivalent in in related field , 7 years years experience of previous field monitoring experience, quality assurance/control and regulatory compliance Required

Other: Experience working in a medical device or regulated industry and Experience with electronic data capture Preferred

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

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 EHS rules and requirements 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