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Clinical Research Associate Jobs

Company

iCell Gene Therapeutics

Address Stony Brook, NY, United States
Employment type FULL_TIME
Salary
Expires 2024-03-10
Posted at 7 months ago
Job Description

Responsibilities

· The role of the Clinical Research Associate is to ensure execution of clinical studies is conducted according to applicable requirements, regulations, and guidance. Both senior and junior positions are available, based on experience.


· Assisting the project teams with the set-up, organization and maintenance of clinical study documentation (e.g Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival


· Collecting, analyzing, and recording data


· Designing trial materials and supplying the research study centers with the quantities that they need


· Assisting and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas


· Overseeing data collection and documentation, and inputting data into systems databases


· Work in collaboration with internal and external colleagues to meet project objectives and timelines


· The senior CRA II is responsible for monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines


Qualifications

  • Strong Administrative and Organizational skills to support several team members
  • Familiarity with various computer document formats, styles, and standards
  • Excellent writing, editing, and communication skills
  • The CRA II candidate will have 3+ years' experience monitoring clinical studies including independent completion of qualification, training, initiation, interim, and close-out monitoring activities
  • A bachelors degree in Health Sciences, Nursing or Medical Biotechnology, or Biological Sciences
  • At least two years of experience as a clinical research associate