Clinical Trials Rep in Carpinteria, CA at Volt

Date Posted: 2/28/2018

Job Snapshot

  • Employee Type:
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Clinical Trials Rep - Carpinteria, CA

Function: assist clinical project groups in relation to planning, execution, reporting of global studies for Companion Diagnostics

Maintain list of labs, assays & studies (CDx & Dako/Agilent-sponsored
Set up site Study binders (Investigator Master File), & other documents for CDx-related studies
Office support for OOO Clin. Ops. staff during lab site visits.
Assist with the development of applicable tools, templates and processes, PowerPoint presentations and Excel spreadsheets related to projects & updates
Support & assist with data entry and quality control review of documents & data forms related to Dako/Agilent-sponsored trials
Assist with remote data monitoring a necessary
Assist with IRB/IEC submissions for Dako/Agilent-sponsored trials – cover letters, review applications, oversee submission process & approvals
Assist with MCA QMS management & revisions, in particular tracking of reviews & approvals
Performs ongoing QC of paper TMF & eTMF

Education: College graduate; degree in healthcare or life science preferred
Experience: Minimum (1 year) experience in clinical research and/or the conduct of investigational clinical trials; oncology and IVD experience a plus.
Other: strong written and verbal communication skills; ability to interact professionally with corporate and external (lab site) personnel; consistent attention to detail and good problem-solving & organizational skills; working knowledge of GCP/ICH and investigational product regulations; knowledge of medical terminology; ability to work in a dynamic environment; strong computer skills preferred

Volt is an Equal Opportunity Employer