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Sr CRA - Senior Specialist, Clinical Research (HYBRID) Irvine, C
IRVINE CA 92604
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-88631173

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Edwards Lifesciences

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  Job posted:   Sun Apr 22, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Sr CRA - Senior Specialist, Clinical Research (HYBRID) Irvine, C
Sr. Clinical Research Associate (CRA) Hybrid - is internally titled as Senior Specialist, Clinical Research. This is a hybrid position combining In-House with Monitoring responsibilities. This hybrid role based in/located in Irvine, CA.


This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.


The Sr. Specialist, Clinical Research will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use and will ensure clinical trials are conducted and reported in accordance with all regulatory requirements.


**Essential Job Functions:**


+ Field monitoring of studies and data collection for clinical trials with moderate complexity, 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, study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop basic 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

+ Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.

+ Other incidental duties.

+ Travel up to 50%


#LI-MO1


Qualifications:


**Required Education/Skills/Experience:**


Required:


+ Bachelor's Degree in related field plus 5 years of field monitoring experience in clinical research

+ Will consider Associate's Degree with 7 years of field monitoring experience in clinical research


Preferred:


+ Cardiovascular device trials.

+ Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification).

+ Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred


Additional Talents and General Expectations:


+ Excellent written and verbal communication skills and interpersonal relationship skills

+ Ability to work independently and as an active member and leader of a team

+ Ability to address delicate situations and effectively manage conflict

+ Ability to lead and motivate others to action

+ Must be able interact with high profile investigators in a positive and constructive manner

+ Knowledge base of medical device regulations, domestic and international

+ Full understanding of regulatory submissions, reporting, and audits

+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations


About Edwards

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.


Title: Sr CRA - Senior Specialist, Clinical Research (HYBRID) Irvine, CA - Transcatheter Mitral & Tricuspid Therapies
Location: USA-USA-California - Irvine
Job Number: 013780

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