This is Bhanu from Intellectt INC; we've got an important role Clinical Research AssociateIrvine, CA with one of our prestigious clients. Interested candidates can please send your updated resume at bhanu@intellectt.com
Role: Clinical Research Associate
Location: Irvine, CA
Onsite role - possibility for hybrid schedule.
Duties
Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
Participate and support in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)
Conduct reviews of documentation needed for internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
Skills
Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Good understanding of regulatory submissions, reporting, and audits Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to build productive internal/external working relationships 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
Thanks & Regards,
Bhanu Poldas
Technical Recruiter
bhanu@intellectt.com
Intellectt Inc.
Direct: 732 784 4384
517 Route 1 South, Suite 1115 Iselin, NJ 08830
WhatsApp: https://wa.me/message/WXRWO7ERLV7HH1
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Human Resources Services
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