Offer summary

Qualifications:

Bachelor's Degree or equivalent in a related field., 3 years of experience in field monitoring, quality assurance/control, and regulatory compliance., Experience in a medical device or regulated industry is required., Strong written and verbal communication skills, along with analytical and problem-solving abilities..

Key responsibilities:

Ensure trial patients' safety by monitoring compliance with protocols and regulatory requirements.

Field monitoring of studies and data collection for clinical trials, ensuring data accuracy and consistency.

Provide oversight and insights into trial activities to principal investigators and study sponsors.

Develop and deliver training on GCPs, protocols, and regulatory documentation requirements.

Job description

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.
• 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 experience Field monitoring experience, quality assurance/control and regulatory compliance Required or
Experience working in a medical device or regulated industry Required or
Experience with electronic data capture Required

Additional Skills:
• Strong 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
• Substantial 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 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