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Clinical Operations Intern

Clinical Operations Intern

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Clinical Operations Intern

  • Location:

    United States of America

  • Sector:

    Clinical Research - Pharma

  • Contact:

    Arslan Sabir

  • Salary:

    US$20 - US$25 per hour

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04112_1663659927

  • Published:

    12 days ago

  • Duration:

    6 Months

  • Startdate:

    ASAP

MSI Pharma are seeking to fill a position for a Top Biotech Organisation based in the USA. The client is looking for Clinical Operations Intern with Data entry experience.

General Duties:

  • Support tasks related to clinical trial study start-up, maintenance, and close-out, including but not limited to working with Clinical Operations study support, start start-up, study management, site management, and compliance teams (i.e., TMF QC and reconciliation, CTMS data entry)
  • Supports the Clinical Operations team in executing business goals and initiatives (i.e., workflow development, process improvement, inspection readiness)
  • Support the development and implementation of tools to improve and streamline processes required by the internalization of studies.
  • Support with drafting and distribution of minutes for staff meetings and role-based forums; maintain meeting topic catalogs for Clinical Operations meetings

Responsibilities:

  • Build basic knowledge of clinical trial operations under close direction and guidance.
  • Participate in various team trainings and meetings (ex. CTA Forum, CST Meeting) to understand clinical trial operations timelines, requirements and lessons learned
  • Learn best practices in clinical operations methodologies, systems, and processes.
    • Includes eLMS Training, participation in CTA Forum, shadowing CTAs
  • Short term or ad hoc support to project teams:
    • Draft agenda and minutes, setup and maintain trackers.
    • Create and maintain repositories (i.e., SharePoint)
    • Maintain meeting topic catalogs and distribute information to teams.
  • Collect and collate data to support process improvement efforts.
    • Create surveys and questionnaires with MS Forms
  • Ad hoc support of Clinical Operations priority initiatives and projects.
  • Provide support within Clinical Operations Americas and other GCO projects, as needed.
    • Assigning Clinical Trial Numbers - Maintain tracker and monitor central mailbox
    • Confidentiality Disclosure Agreements - Maintain repository and monitor central mailbox
    • Confidentiality Disclosure Agreements - Archive and support teams with search
  • Document archiving (hardcopy and electronic).
    • Support with on-site preparation and tracking prior to off-site storage.
  • Support Trial Master File review.
    • Content and completeness QC using ALCOA-C and study specific eTMF Management Plan
    • eTMF close-out activities
  • Complete data entry in Clinical Trial Management System.
    • Support with ad hoc data entry and maintenance

This position can be remote, but will require travel to sites during audits and special projects