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Company Contact Info

  • Irvine, CA 92612
  • Bridget Burns

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Clinical Trial Associate

Alpha Consulting • Irvine, CA

Posted 1 month ago

Job Snapshot

Biotechnology, Pharmaceutical

Job Description

Project Description:
  • Support study feasibility activities and perform database/web searches for sites as needed.
  • Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
  • Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.
  • Reconcile and transmit all essential documentation to CDIC as per Forest policy.
  • Track and assist with processing site/vendor payments. Follow up on any issues as required.
  • Collect and track patient enrollment information and update study management reports as necessary.
  • Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
  • Assist senior team members with in the planning, preparation, and on-site support of investigators meetings.
  • Generate reports in various applications to assist the Clinical Scientist to perform clinical data review.
  • Assist with ongoing data review and discuss comments with the clinical study team as needed.
  • Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
  • Provide input and support in the development and distribution of monthly site newsletters.
  • Support the Regional Site Managers by providing study related information and supplies, as requested.
  • Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
  • Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
  • Contribute to process improvement efforts including task forces and committees. 
  • Support clinical team with requests from management as needed. 
  • May deliver training related to day-to-day responsibilities for new CTA and CS hires within department. 
  • May provide administrative support to manager/group as assigned.
  • Manage calendars and appointments. Resolve scheduling conflicts as needed. 
    Manage and coordinate travel requirements for group, consultants, and partners. 
  • Prepare and oversee expense account reporting. May contribute to tracking budgets as needed.
  • Support document filing and organizing as needed.
  • Schedule and coordinate new hire candidate interviews. 
  • Coordinate and process office supply orders. 
  • Function as a back up to general Clinical Scientist activities as needed. 
Required Skills:
  • Associate degree or higher preferred.
  • 1-2 year relevant experience in pharmaceutical industry or CRO.
  • Experience supporting clinical trials preferred.
  • Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus.
  • Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat.
  • Strong skills with Microsoft Excel required.
  • Experience using electronic data capture (EDC) systems is a plus.
  • Must possess excellent skill/ability in the following:
    • Oral and Written Communication
    • Organizing
    • Judgment and Problem Solving
    • People Relationships
    • Initiative and Accountability
    • Ability to manage multiple tasks
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:

Job ID: 19-00876
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