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Clinical Trial Administrator

New Jersey All, NJ

Job Type: Clinical Job Number: JN -012020-26194 Region: New Jersey All

Job Description

  • Maintains and supports the logistical and administrative aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
  • The incumbent is also a pivotal point of contact and support for the clinical trial team
  • Assists with the set-up, management and maintenance of electronic Trial Master Files (eTMF), in accordance with GCP
  • May be involved with set up, management and maintenance of other program/study related files and electronic filing systems
  • Supports the clinical team regarding preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents as applicable
  • Coordinates with clinical supply staff as needed to ensure adequate availability for study need
  • Coordinates management and maintenance of study documents including quality control checks as directed by operations trial leads
  • Coordinates archiving of study documents as directed by operations trial lead
  • May support training of new users on eTMF and SOPs
  • As directed, will arrange and participate in meetings including preparation and distribution of agendas, meeting materials and taking/distributing meeting minutes
  • Maintains up-to-date study team contact lists
  • Assists with the review, tracking and processing of payments/invoices related to investigators, consultants and service providers
  • Performs general clerical duties in support of clinical trials, e.g., copying, faxing, mailing, filing, and making travel/meeting arrangements
  • Performs additional tasks as required to support Clinical and Technical Operations managers

Requirements:

  • Bachelor s Degree
  • 3+ years of Clinical Trial Associate/Support experience from a pharmaceutical, biotech or CRO company


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