Clinical Trials Management Associate : 19-01501

Foster City, CA 94404

Posted: 04/09/2019 Job Category: Clinical Affairs Job Number: 12035346
Akraya is looking for a Clinical Trials Management Associate – II for one of our clients. If the job description below is a fit, please apply directly or call Vaibhav Kalbende & 408-512-2355. 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 Trials, Biomarker, Study Management, CRO, Word, PowerPoint and Excel 
Duration: Long Term
Tax Term: W2 Only

Description:
  • Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas 
  • Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in client and Collaborative (CO) programs 
  • Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
  • Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial 
  • Provides sample management expertise to the Study Management Teams (SMTs) 
  • Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent. 
  • Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting 
  • Primary interface for operational activities between the SMT and biomarker laboratory vendors
  • Provides the day-to-day operational management of biomarker vendors to ensure 
    delivery against contracted scope of work 
  • Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions 
  • Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams 

    Knowledge: 
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies 
  • Working knowledge and experience with Word, PowerPoint and Excel 

    Experience and Skills: 
  • At least 3+ years of experience and a BS or BA in a relevant scientific discipline (eg. Clinical Operations and/or Sample Management) or 
  • At least 3+ years of experience and an RN (2 or 3 year certificate) 

  Please apply directly with your updated resume or call Vaibhav Kalbende @ 408-512-2355
 
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.

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