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Sr. Clinical Research Associate - Transcatheter Heart Valve

Location
Irvine, CA

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Sr. Clinical Research Associate - Transcatheter Heart Valve','014711','!*!This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Sr. Specialist, Clinical Research Monitoring will assist the Clinical Project Manager and study team to ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.This is a field based positon covering the Mid to North Eastern coast territory. Successful hire will reside in Atlanta GA, Raleigh NC, or Charlotte NC.Essential functions: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 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.Travel up to 75%This is a field based positon covering the Mid to North Eastern coast territory. Successful hire will reside in Atlanta GA, Raleigh NC, or Charlotte NC.#LI-MO1','!*!Required Experience, Education and Skills:Bachelor’s Degree in a Life Sciences or related field is requiredMinimum of 5 years prior hands-on field clinical research experience is required; encompassing all aspects of the clinical process is preferredMust have experience with Cardiovascular device trials, Cath Lab, operating room and/or intensive care unit familiarity.Additional Required Skills:Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skillsExperience with electronic data captureProven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machineryDemonstrated problem-solving and critical thinking skillsStrong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertiseUnderstanding of medical device regulatory requirements and documents, device accountability and adverse events reportingTechnical writing skills (protocols, CRF development, study tools)Ability to communicate and relate well with key opinion leaders and clinical personnelAbility to travel up to 75%.Ability to cover the Mid to North Eastern coast territory.  Reside in the area of Atlanta GA, Raleigh NC or Charlotte NC.','!*!**MEMBERS ONLY**SIGN UP NOW***. 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, **MEMBERS ONLY**SIGN UP NOW***. 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.','!*!**MEMBERS ONLY**SIGN UP NOW***. 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, **MEMBERS ONLY**SIGN UP NOW***. 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.','Clinical Affairs','USA-USA-California - Irvine','','Sr. Clinical Research Associate - Transcatheter Heart Valve

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