Field Based Clinical Research Associate

  • location: Norristown, PA
  • type: Permanent
  • salary: $85,000 - $90,000 per year
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job description

Field Based Clinical Research Associate

job summary:
Position: Field Based Clinical Research Associate

Seeking an experienced CRA, local to the Norristown area, who will assist with administration of clinical research projects, such as: site and investigator recruitment, collecting investigator documentation, site management and site monitoring.

 
location: Norristown, Pennsylvania
job type: Permanent
salary: $85,000 - 90,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Assist with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing and maintaining proper status reports of activities at investigative sites through the duration of a clinical trial and completing other technical tasks to completion.
  • Qualify, initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
  • Assist and manage training of new Clinical Research Associates.
  • Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human and or animal subjects.
  • Ensure subject safety through diligent monitoring of the site's compliance with study protocols and the collection of adverse event information
  • Update, track and maintain study specific trial management tools/system.
  • Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with investigational product handling procedures. Ensure that all adverse events are collected pursuant to GCP.
  • Report, write narratives and follow-up on reported serious adverse experiences.
  • Assist with generation and reconciliation of queries to investigation sites to resolve problem data.
  • Assist and manage project budget and investigator site budget as needed, attend project team meetings, plan, attend and participate in investigator meetings, and communicate with clients.
  • Generate and track investigational product shipments and storage.
  • Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.
 
qualifications:
  • Bachelor's degree required in the Biological / Health Sciences or a related fields required.
  • Pharmaceutical industry or related experience required.
  • Minimum of 3 years' experience as a Clinical Research Associate required.
  • Ability to travel up to 60%, including overnight.
  • Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously.
  • Proficiency in MS Word, Excel and Outlook.
  • Detail oriented, self-motivated.
 
skills: CRF, Clinical research, GCP (Good Clinical Practice), Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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