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Assoc Clinical Research Specialist (CRA I)

TechData Service Company LLC Irvine, CA
  • Expired: 29 days ago. Applications are no longer accepted.
Job Description

Location: Irvine, CA

Duration: 12 months with a chance to extend

Job Duties: 
We are looking for 2 people. It can either be 2 Assoc Clinical Research Specialists (CRA I)  , or 1 CRA I and 1 Clinical Research Specialist (CRA II).
This position and rate are considered a "CRA I". Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
 
Participate 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 Assist with ECR submissions in Ignite
 

Skills: Top Requirements:


1. Medical Device / Pharma clinical experience
2. Site management (in house CRA) / TMF experience
3. Understanding clinical data
4. Able to work onsite following the blue/green model
 
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


Education: Bachelor's Degree in related field of study and MINIMUM 1 year of previous experience as a clinical research associate. HIGHLY PREFERRED 2 years or more.

Skills and Experience:

    • AUDITS
    • CLINICAL RESEARCH
    • CLINICAL TRIAL
    • CRA
    • CRA II
    • Additional Skills:
    • DOCUMENTATION
    • ECR
    • EHS
    • FDA
    • LOGISTICS
    • MEDICAL DEVICE
    • POLLUTION
    • SITE MANAGEMENT
    • SOPS
    • AUDIT
    • CLINICAL SYSTEMS
    • CLINICAL TRIALS
    • EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
    • MICROSOFT OFFICE
    • MS OFFICE
    • PROBLEM-SOLVING
    • TRIAL MANAGEMENT


     

    TechData Service Company LLC

    Address

    Irvine, CA
    92602 USA

    Website