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Clinical Studies Specialist

Clinical Studies Specialist

Spectraforce TechnologiesRaleigh, NC, United States
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Position Title : Clinical Studies Specialist - 100% Remote

Duration : 2 yrs

What are the top 3-5 skills, experience or education required for this position :

  • Bachelor's degree or international equivalent preferred. Minimum 4 years relevant industry experience in clinical document management or equivalent experience required. If no BS, a total of 6 years professional clinical research relevant work experience.
  • Proven analytical and critical thinking skills.
  • Proficient knowledge of clinical documentation business procedures and compliant to clinical documentation processes, identify gaps and propose solutions.
  • Capable of working autonomously with limited oversight.
  • Proven oral and written communication skills; ability to facilitate cross-functional team meetings.

Purpose :

  • Performs key operational activities across the Clinical Documentation Center for master files through life cycle.
  • Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files.
  • May be aligned by Therapeutic Area but expected to work across all areas of the organization.

    • Responsibilities :

  • Applies critical thinking to ensure real-time inspection readiness of clinical documentation by :
  • Investigates and proactively resolves issues
  • Runs and performs review of reports and dashboards within eTMF
  • Produces eTMF metrics
  • Communicates to Master File owner(s) "root cause" analysis and potential data integrity concerns
  • Leads to completion of the final reconciliation / review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).
  • For CRO managed study TMFs :
  • Conduct QC of artifacts (may also include uploading and classifying)
  • Involvement with transfer of CRO TMFs into eTMF system
  • Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files) :
  • Conduct data integrity checks
  • Run & analyze reports for TMF completeness
  • Work with the assigned CDA to follow-up on outstanding items with other functional areas
  • Contribute to completion of pre-inspection requests
  • During an inspection :
  • Function as the subject matter expert of the eTMF system navigation , including being present in the "front room" with the Auditors / Inspectors
  • Participate in responding to auditor / inspector requests (may be required to put the response together)
  • Conduct TMF conversion activities ; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).
  • Review regulatory documents / packages for approval of Investigational Product (IP) release and work with Artifact Owner(s) to correct errors.
  • Provide approval for release of IP to investigator sites.
  • Provides suggestions for CDC work instructions / job aides and contributes to functional area continuous improvement projects and / or work streams.
  • Complies with GCP, SOPs and functional area processes.

    • Required

    Preferred

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    Clinical Specialist • Raleigh, NC, United States