This site uses cookies. To find out more, see our Cookies Policy

Associate, Clinical Trial Management in Irvine, CA at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/27/2018
  • Job ID:
    917418

Job Description


We are seeking an Associate for Clincial Trials. Please send updated resumes to mmiller@apexlifesciences.com

Experience:

  • 3+ years relevant experience in pharmaceutical industry or CRO
  • Experience supporting clinical trials preferred
  • Handle and prioritize multiple tasks simultaneously
  • Work effectively in a team/matrix environment
  • Understand technical, scientific and medical information
  • Handle conflict management and resolution
  • Familiarity with clinical study budgets and accruals

Candidate must have a good understanding of the following:

  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
  • Knowledge of concepts of clinical research and drug development
  • Prefer but not a must have - Ophthalmology area experience

Qualifications:

  • Bachelors degree or higher
  • Science degree preferably in science or health-related field
  • Previous experience of working on a clinical study Other
  • Position is Irvine, CA based but may have option to work from home 2 days per week Position Summary:
  • supports CTM/OSL in ensuring the assigned clinical study(ies) are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures

 Assist with:

  • regional site feasibility, when necessary
  • tracking of site training, certification, delivery of ancillary supplies, etc. necessary for site activation
  • development of study-specific documents, when necessary
  • regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions
  • periodic review of protocol deviations
  • database lock activities (interim or final lock)
  • regional study drug management: track shipping or storage site temperature excursions
  • regional trial master file management (TMF): ensure all documents are appropriately filed in the TMF
  • regional enrollment management: site activation and enrollment tracking for monthly reporting

#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.




917418