Ensure trial patients’ safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
Key Responsibilities:
• 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.
• Develop and deliver technical 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. Act as a mentor to new or junior level employees.
• 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 Boards, Contract, and Training, developing process improvements.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• 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.
• Edit/amend informed consent documents.
• Other incidental duties
Required Experience:
• Bachelor’s Degree in related field , A minimum of five years experience of previous field monitoring experience
• Associate’s Degree in related field , A minimum of seven years experience of previous field monitoring experience, quality assurance/control and regulatory compliance
• Experience with electronic data capture
Preferred Experience:
• Experience working in a medical device or regulated industry
Additional Expectations:
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
• Demonstrated problem-solving and critical thinking skills
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• 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
• Experience in training new hires
• 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
