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Clinical Study Monitor

Cranford, NJ 07016

Posted: 12/04/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2052

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines.

Responsibilities:
  • Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
  • Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  • Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
  • Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
  • Independently coordinate ongoing and upcoming monitoring assignments
  • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
  • May assist in the development and writing of clinical trial monitoring plans.
  • May provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
  • Participate in regular monitoring team group meetings.
  • May assist with CRA in-house site related responsibilities
  • May participate in Clinical Operations Committees


Qualifications:
  • Bachelor’ s degree in a related health profession or nursing
  • 2+ years of oncology monitoring experience
  • Knowledge of FDA regulatory requirements, ICH guidelines, GCP, and commonly used study processes
  • Proficient in RDE, CTMS, Excel and MS Word
  • Experience with data listing and patient profile review is a plus.
  • Ability to work effectively in teams as well as independently
  • Strong verbal and written communication skills
  • Ability to prioritize and manage multiple tasks and responsibilities
  • Excellent communication skills, both oral and written
  • May be home or office based depending on location
  • National Travel: Approximately 50 – 60%
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