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Clinical Research Associate – Monitor

  • Ref: 301984
  • Type: Option-to-Hire
  • Location: Rochelle Park, NJ
  • Industry: Pharmaceuticals
  • Job Level: Entry Level
  • Pay: Negotiable

Opportunity Description

ENTRY LEVEL-Independently monitors/manages investigative sites to ensure that all clinical trial activities conform to the protocol, GCP-ICH guidelines, local regulations, statutes and SOPs.  Assists the CPM as needed with other clinical trial activities as assigned

Company Information

Pharmaceuticals

Job Duties

  • Conduct site qualification, monitoring, close-out, and monitoring oversight visits
  • Generate relevant monitoring visit reports for submission to CPM in accordance with the study monitoring plan
  • Assist in the review of remote and on-site clinical data as needed under the direction and         supervision of the CPM in alignment with the trial monitoring plan
  • Serve as a point of contact for Investigator site personnel
  • Assist with query resolution and data cleaning
  • Assist with maintenance and quality review of the Trial Master File
  • Other tasks assigned by the Dir. Clinical Operations to support the operation of the department and/or clinical trials
  • Update and submit periodic reports for Sunshine Act payment tracking
  • Facilitate full execution of clinical contracts then addition to legal documentation systemInvoice management including preparing, processing, and tracking invoices for multiple studies as well as allocating cost to spend categories to assist with management of study budgets

Education

Minimum 4 year degree in medical, pharmaceutical, sciences preferred

Experience & Skills Required

  • Knowledge of the pharmaceutical industry
  • Any on-site monitoring experience in Clinical R&D a ++
  • Willing to travel
  • Excellent written and verbal communication skills
  • Strong organisational, documentation and interpersonal skills
  • Team oriented