Responsible for assisting study team in conducting clinical trials in various therapeutic areas. Contributes to clinical research study development, implementation, conduct, and management.

ESSENTIAL FUNCTIONS PERFORMED

  • Contribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.
  • Assist in developing and overseeing study operational plan(s).
  • Contribute to study team for trial start-up, conduct, and close-out activities according to industry and corporate standards.
  • Participate in study data review and assist with patient outcome narrative writing and other data review activities as assigned.
  • Participate in initiation, training and monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols; take ownership for data completion and accuracy.
  • Contribute to creation of study documentation including clinical protocols, study tools, informed consent, investigator brochures, and clinical study reports.
  • Perform other related duties and tasks, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

  • BS in Science, Life Science or related field a plus
  • 1-3 years experience in medical device, pharmaceutical drug development, biotech or CRO industries monitoring and managing clinical trials
  • Experience complying with GCP, ICH, ISO and FDA regulatory requirements
  • Willing to be held accountable for deliverables
  • Must be highly organized and detail oriented
  • Experience interfacing with multiple vendors/contractors
  • Proven ability to handle multiple projects and changing priorities
  • Must be results-driven and exhibit a sense of responsibility and outcome ownership
  • Clear and concise in verbal and written communication, fosters smooth flow of
    timely and relevant information
  • Strong initiative and positive attitude
  • Ability to travel to clinical sites, domestic and foreign, up to 25%.
Submit Resume

To apply for this job email your details to info@clinlabstaffing.com