Clinical Operations Regulatory Specialist

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

Responsibilities

  • Responsible for day to day system administration and overall system maintenance.
  • Responsible for training all users of the eTMF and ensuring training program is kept up to date with system and procedure trainings.
  • Responsible for overall quality, maintenance, and completeness of Trial Master Files.
  • Identify trends or quality concerns and oversee resolution of any issues.
  • Work closely with Information Technology to ensure system validation is maintained.
  • Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements.
  • Act as a liaison between the Site IRBs and Clinical team to resolve queries and concerns.
  • Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.
  • Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings.
  • Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
  • Other duties as assigned.

Qualifications

  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or related field.
  • A minimum of 1 year of clinical research experience in academic and/or industry settings
  • Prior eTMF administration required.
  • Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2).
  • Knowledge of, and direct experience with Trial Master Files, experience with electronic TMF systems is required.
  • Fundamental knowledge of the conduct of clinical trials is preferred
  • Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment.
  • Must be able to work independently and professionally.

 

Job Location: Remote

Equal Opportunity Employer

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