Senior Specialist, Clinical Research Monitoring – Heart Valve Therapy
April 6, 2018
Full Time - Experienced
Senior Specialist, Clinical Research Monitoring (In-House CRA with Field Monitoring, Irvine, CA) – Heart Valve Therapy
Edwards Lifesciences surgical Heart Valve Therapy (HVT) group has an exciting opportunity for a Sr. Specialist, Clinical Research Monitoring. This role is an In-House CRA with Field Monitoring - Based out of Irvine, CA.
The Sr. Specialist, Clinical Research Monitoring Operations ensures trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
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.
Up to 50% travel, Continental United States and Canada.
In-House CRA with monitoring responsibilities.
Position based out of and located in Irvine, California.
Bachelor's Degree with 5 years (or Associate’s Degree with 7 years) of hands-on clinical research experience encompassing all aspects of the clinical process; including field monitoring experience, quality assurance/control and regulatory compliance.
Medical Device Industry.
Cardiovascular device trials.
Electronic Data Capture.
Cath lab, operating room and/or intensive care unit familiarity.
Site pre-qualification visits through close-out visit experience.
Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification).
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required.
Demonstrated problem-solving and critical thinking skills.
Experience with electronic data capture preferred.
Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery.
Experience working in a medical device or regulated industry preferred.
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.
Internal Number: 013539
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.