Regulatory Document Coordinato
Smith Hanley Consulting Group - Florida

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  • Coordinate activities as related to the conduct of all phases of pharmaceutical, biotechnology and medical device clinical trials
  • Collection and maintenance of regulatory documents from investigative sites
  • Review and approval of site regulatory documents, including financial disclosure forms, Form 1572’s/Investigator Agreement, CVs and medical licenses, etc. for completion, accuracy and compliance with HCRI, FDA and GCP requirements
  • Creation and distribution of regulatory packets and Investigator Binders to investigative sites
  • Develop and maintain databases for tracking of regulatory documents, work flow process and other essential trial related documents
  • Communicate with sites on regulatory document needs, document insufficiencies and document expirations
  • Coordinate and distribute Investigator payments and Site/IRB invoices
  • Review Informed Consent forms and other study specific forms as first reviewer
  • Generate and maintain study and site specific trial master files
  • Organize and preparation of trial related materials and presentations for Investigator and/or coordinator meetings
  • Work with in-house study team and Sponsor in identifying and screening qualifications of appropriate investigative sites
  • Help to maintain a site/investigator selection system/process
  • Provide centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities
  • Provide ongoing site management support through project completion
  • Facilitate general communication among the research centers, HCRI project teams, sponsors, site monitors and vendors relative to the responsibilities itemized above

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