Clinical Trial Assistant

Location: Aventura, FL, United States
Date Posted: 05-26-2016
Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies. Biorasi hires talent and personality, not position holders.

We’re a non-traditional work environment requiring only top performers. Every team member is a stock-holding owner and our culture reflects it. Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.

This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.

Responsibilities:
  • Support Clinical Trial Manager (CTM) in preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).
  • Support CTM preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets).
  • Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial.
  • Filing of required clinical trial documents maintained within Clinical Trial Master File (CTMF) throughout the clinical trial.
  • Prepares necessary study supplies for clinical trials and processes site requests for shipping supplies, as needed.
  • Assisting the study teams in meeting timelines.
  • Partake in regular team meeting / teleconferences.
  • Participate at Client Presentation Meetings as necessary.
  • Participate at Investigator Meetings as necessary
  • Communicate any out of scope issues to upper management as soon as identified.
  • Other duties as assigned.
 
Qualifications and Experience Required:
  • Associates or Bachelor’s Degree in biomedical sciences or related scientific discipline
  • 1 - 2 years of clinical research experience
  • Excellent verbal and written communication skills required.
  • Excellent organizational, multi-tasking and time management skills required.
  • Sound knowledge of medical terminology.
  • Excellent verbal and written communications skills.
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