Clinical Research Associate in Emeryville, CA at Apex Life Sciences

Date Posted: 9/11/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/11/2018
  • Job ID:
    885369

Job Description


Primary Job Function:

  • Performs site monitoring visits (SIV, IMV, Close-Out) and site management activities to assess the site’s ability to effectively and continuously conduct the trial per the protocol, GCP, and regulatory requirements
  • Manages clinical study database, including ensuring the integrity of the data submitted on Case Report Forms (CRFs) by careful source document review and monitoring
  • Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample tracking
  • Files documents in the Trial Master File (TMF)
  • Generates project plans, especially those related to site management, monitoring and reporting
  • Manages and tracks clinical and non-clinical supplies, including purchase and shipping
  • Works closely with other clinical team members and external partners, e.g. CROs and vendors, to facilitate timely resolution of trial and/or clinical issues
  • Identifies and evaluates additional resources necessary for regulatory and clinical projects
  • Understands FDA guidelines as well as Good Clinical Practice (GCP)
  • Promotes the values and ethics of our company through all interactions with teammates and potential collaborators, customers, and vendors

Education: Bachelor’s or master’s degree in science, nursing, or equivalent

Skills: The ideal candidate will possess most of the following skills and will be excited to learn the rest:

  • 2+ years clinical research experience in medical/diagnostic device or pharma with independent clinical monitoring experience
  • Experience with electronic data capture (EDC) systems, trial master files (TMF), electronic medical records (EMR), and clinical trial databases/clinical data management systems
  • Strong verbal and written communication skills
  • Excellent organizational, record retention, time management, decision-making, customer service, multi-tasking and interpersonal skills
  • Knowledge of FDA and global regulation of medical devices, e.g. PMA, 510(k), IDE, CLIA waiver, CE Mark
  • Experience with establishing or working with a quality management system (QMS)
  • Ability to work independently and collaboratively to find creative and resourceful solutions to problems

#LI-MM2

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




885369