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Edwards Lifesciences · 3 days ago

Specialist, Clinical Research Monitoring

United States

Full-time

Remote

Mid Level

$85K/yr - $120K/yr

Edwards Lifesciences is a leader in innovative medical technologies, and they are seeking a Specialist in Clinical Research Monitoring to contribute to their Clinical Affairs team. The role involves overseeing clinical trials, ensuring compliance with regulatory requirements, and providing insights into trial activities to optimize patient outcomes.

BiotechnologyHealth CareMedicalMedical Device

Comp. & Benefits

Responsibilities

Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements

Providing 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 recommending and developing process improvements

Verifying 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

Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition

Developing and delivering 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

Contributing to the development of clinical protocols, informed consent forms, and case report forms

Editing/amending informed consent documents

Qualification

Clinical research certificationField monitoring experienceRegulatory complianceMS Office SuiteCardiovascular anatomy knowledgeTechnical writing skillsAnalytical skillsProblem-solving skillsCommunication skillsInterpersonal skills

Required

Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria

Ability to travel up to 75% domestically