Abiomed
Clinical Research Specialist II
Job#: 17CO-03
Positions: 1
Posted: 05/15/2017
Job Type: Full Time
Location: Danvers, MA
Department: Clinical Research
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Job Description

The CRS II will assist in designing, planning and conducting high quality clinical research trials or data registries to ensure safety and effectiveness of Abiomed products.  

Job Responsibilities:

  • Conduct periodic monitoring activities with investigative sites, including reviewing case report forms (CRFs), performing source document verification, monitoring compliance with good clinical practice (GCP) guidelines and FDA regulations and monitoring device accountability
  • Conduct site initiation and study closeout activities
  • Prepare, modify and distribute study materials such as CRFs, study reference manuals and monitoring guidelines/manuals
  • Provide training to site personnel
  • Participate in investigator meetings
  • Negotiate budget, contract and IRB/EC approval with sites and investigators
  • Assist with the preparation of FDA submissions
  • Other responsibilities as assigned




Skills/Requirements
  • Bachelor's or higher degree mandatory
  • 2 -5 years of clinical research specialist experience
  • Experience in Class III cardiovascular device studies preferred
  • Ability to work on multiple protocols at the same time
  • Strong working knowledge of guidelines, systems for clinical trial management and of ICH, FDA and GCP regulations and practices
  • Proven track record of having good investigator and site relations
  • Excellent interpersonal, verbal and written communication skills
  • Attention to detail and strong organizational skills
  • Strong knowledge of Microsoft Office Suite and Outlook
  • Must be able to travel up to 25% overnight

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.

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