Clinical Project Associate : 19-00516

Foster City, CA 94404

Posted: 03/12/2019 Job Category: Clinical Affairs Job Number: 11825035
Akraya is looking for a Clinical Project Associate  for one of our clients. If the job description below is a fit, please apply directly or call Ashu Pandey & 408-907-2228). If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.

Primary Skills: Clinical, Clinical research. Clinical trial, ICH, FDA and or EMEA Regulations, GCPs, TMF, eTMF
Duration:  12 Months (Possibility for Extension)
Contract Type: W2 Only

Job Responsibilities:
  • May assist in the development and upkeep of administrative support tools to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File for studies.
  • Serves as the point of contact for study sites and contract monitors for clinical supplies, document collection and preparation for close-out visits.
  • Assists Clinical Operations teams with study set-up (preparation of study materials, Investigator Meeting planning, etc.)
  • Develops and keeps Clinical Trial tracking program up to date with site contact, initiation and enrollment details
  • Demonstrates a deeper understanding of the science behind Clinical Operations
  • Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
  • Provide input and assist with harmonization of Clinical Operations databases and tracking tools.
  • Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database
  • Processes re-supply drug shipments.
  • Order and maintain inventory of clinical supplies.
  • Order and ships case report forms.
  • Assists with development of documents for site binders. Assembles and coordinates distribution of site binders.
  • Serves as CRA back up providing verbal and written communication with study personnel.
  • Under close supervision reviews and participates in the quality assurance of data or documents.
  • Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes.
  • The position interacts with other departments, as directed, to complete assigned tasks.
  • May assist with monitoring visits under the direct supervision of senior staff.
  • Travel may be required.
  • Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings.
  • 2-3+ years of experience with BS degree in a related scientific discipline.
  • Travel may be required.
  • Must be familiar with Word, PowerPoint, and Excel.
  • Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
  • Must be able to work both independently and as part of a team.

Please apply directly with your update resume or call Ashu Pandey & 408-907-2228
About Akraya
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.