Clinical Research Associate II

US-MA-Bedford
5 months ago(7/19/2017 4:28 PM)
Job ID
2017-1012
# of Openings
1
Category
Clinical

Overview

We are seeking a CRA II with at least 2 years related experience to include some site monitoring. Reporting to the Clinical Project Manager this individual will assist and provide support to the members of the clinical trial team in order to facilitate the clinical trial processes and execution of clinical trials. The CRA II will assist with designing, implementing and maintaining clinical trials; writing protocols, case report forms and consent forms; and recruiting and selecting investigators and ensuring good clinical practices are followed. 

Responsibilities

  • Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
  • Assist in designing, planning, and implementing a variety of clinical research projects
  • Assist in the design of study protocol, case report forms, informed consent to allow for accurate and thorough data collection to support the product through the approval process
  • Review study records including case report forms, consent forms, and other materials
  • Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements
  • Organize data in systematic manner to allow for efficient and accurate clinical reports.
  • Perform site visits to ensure regulatory and study requirements are being fulfilled
  • Provide on-site support in the operating room or clinic during clinical study procedures
  • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
  • Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities

Qualifications

  • Bachelor's Degree in a Health or Science field preferred
  • Minimum of 2 years of related experience to include some monitoring
  • Excellent written and oral communication skills
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
  • Excellent organizational skills and attention to detail
  • Ability to travel approximately 35-40% for site training, clinical study procedure support, monitoring responsibilities and educational seminars

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