This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.
The Monitoring Clinical Research Associate II will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. Travel up to 75%.
• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• 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), and recommend and develop process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• 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.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Edit/amend informed consent documents.
• Other incidental duties
Education and Experience:
Bachelor's Degree or equivalent in in related field , 3 years years experience of previous field monitoring experience Required or
Associate's Degree or equivalent in in related field , 5 years years experience of previous field monitoring experience, quality assurance/control and regulatory compliance Required or
Other: Experience working in a medical device or regulated industry Preferred
Other: Experience with electronic data capture Preferred
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Demonstrated problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Technical writing skills (protocols, CRF development, study tools)
• Ability to communicate and relate well with key opinion leaders and clinical personnel
• 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