Center for Health Care Strategies logo
Center for Health Care Strategies

Better care where it's needed most

Quality Assurance and Research Education Coordinator

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 51-200Since 1998H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

18 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Quality Assurance and Research Education Coordinator

Center for Health Care Strategies

• Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. • Assist in the development and writing of clinical trial monitoring plans based on risk based monitoring. • Adhere to monitoring plans; 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/remote 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. • Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation. • Provides training programs for clinical research associates developed by the Quality Assurance and Research Program. • Participates in education of new team members as well as ongoing education of teams based on gaps identified through internal audits, sponsor monitoring visits, changes in regulations, departmental/corporate policies and other factors as determined by department leadership. • Must be willing to travel up to 30% of the time as needed. • Must be able to maintain strict confidentiality.

Job Requirements

  • Certified Clinical Coordinator either through SOCRA or ACRP required
  • Bachelor's degree required
  • A minimum of 3 years of relevant experience required
  • Experience dealing with regulatory agencies required

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