PRAHS

  • Clinical Data Coordinator

    Job Locations (All) | US-PA-Blue Bell
    Posted Date 6 days ago(11/7/2018 2:32 PM)
    ID
    2018-50232
  • Overview

    Receive requests through CTMS DE Specific mailbox on Sponsor desktop (using Virtual Desktop (VDI)). All requests are logged into an Access Database and assigned an ID number which is entered on the request email. Assignments are then assigned to individual team members by franchise and placed in the team member’s inbox folder. The team member will then verify that all mandatory information has been provided on the proper documents. This information includes but is not limited to site number, PI, TC, LSM, CRA, Monitor Manager, Protocol/Site and Country levels for Contacts, Accounts, Team History, Activity plans, Milestones, Requester name, Protocol & Site number, PI, LIRB Name with full address, IRB Chairman, OHRP Date, IRB Account, Site level, Account level, Document Tracking tab. Confirm Accounts/Contacts are available in Sponsor system, if not either add into system or send all Ex-US requests to Country LRAs for entry. For all tasks if there are any discrepancies in the information provided the team member will reach out to the requester, management or reference aids to rectify discrepancy.

    Responsibilities

    • Pre-Validated Sites Lists – verify that all mandatory information has been provided on spreadsheet. In Sponsor system enter site number, PI, TC, LSM or CRA, Monitor Manager – CRM, if the contacts and .or accounts are not in Sponsor system. If Ex-US, the information must be sent to assigned Country LRA to be entered. Information needs to be added at Protocol Site and Country levels for Contacts, Accounts, Team History, Activity Plans and Milestones.
    • Manual Outsourced Tracker – Insure all mandatory information is provided on tracker. Trial number, site numbers, account information, contact information, country/site/trial milestones information. Confirm accounts and contact information is available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system.
    • ODE Outsourced Trackers – Insure all mandatory information is provided on the tracker. Trial number, site numbers, account information and contact information. All protocol, site and country milestones are entered from a feed. Confirm accounts and contacts are available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system
    • ISIF/ISI Change Forms – Insure all mandatory information is provided on the ISIF/ISI Change form including but not limited to trial number, site number, account information, contact information, milestone information.

     

    ·         Pre-Validated Sites Lists – verify that all mandatory information has been provided on spreadsheet. In Sponsor system enter site number, PI, TC, LSM or CRA, Monitor Manager – CRM, if the contacts and .or accounts are not in Sponsor system. If Ex-US, the information must be sent to assigned Country LRA to be entered. Information needs to be added at Protocol Site and Country levels for Contacts, Accounts, Team History, Activity Plans and Milestones.

    ·         Manual Outsourced Tracker – Insure all mandatory information is provided on tracker. Trial number, site numbers, account information, contact information, country/site/trial milestones information. Confirm accounts and contact information is available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system.

    ·         ODE Outsourced Trackers – Insure all mandatory information is provided on the tracker. Trial number, site numbers, account information and contact information. All protocol, site and country milestones are entered from a feed. Confirm accounts and contacts are available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system

    ·         ISIF/ISI Change Forms – Insure all mandatory information is provided on the ISIF/ISI Change form including but not limited to trial number, site number, account information, contact information, milestone information.

     

     

    ·         IRB Forms from Pics – Insure all mandatory information is provided on the IRB Forms from Pics. This will include requester name, protocol and site number, PI, LIRB name with full address, IRB Chairman, OHRP date, IRB account, site level, account level and document tracking tab.

    ·         For all tasks if there are any discrepancies in the information provided the CTMS DE team member will reach out to the requester, management or reference aids provided to rectify the discrepancy.

    ·         Pre-Validated Sites Lists – verify that all mandatory information has been provided on spreadsheet. In Sponsor system enter site number, PI, TC, LSM or CRA, Monitor Manager – CRM, if the contacts and .or accounts are not in Sponsor system. If Ex-US, the information must be sent to assigned Country LRA to be entered. Information needs to be added at Protocol Site and Country levels for Contacts, Accounts, Team History, Activity Plans and Milestones.

    ·         Manual Outsourced Tracker – Insure all mandatory information is provided on tracker. Trial number, site numbers, account information, contact information, country/site/trial milestones information. Confirm accounts and contact information is available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system.

    ·         ODE Outsourced Trackers – Insure all mandatory information is provided on the tracker. Trial number, site numbers, account information and contact information. All protocol, site and country milestones are entered from a feed. Confirm accounts and contacts are available in Sponsor system, if not add for US, send all Ex-US to Country LRA for entry. Make any requested updates to current information in Sponsor system

    ·         ISIF/ISI Change Forms – Insure all mandatory information is provided on the ISIF/ISI Change form including but not limited to trial number, site number, account information, contact information, milestone information.

    ·         IRB Forms from Pics – Insure all mandatory information is provided on the IRB Forms from Pics. This will include requester name, protocol and site number, PI, LIRB name with full address, IRB Chairman, OHRP date, IRB account, site level, account level and document tracking tab.

    ·         For all tasks if there are any discrepancies in the information provided the CTMS DE team member will reach out to the requester, management or reference aids provided to rectify the discrepancy.

    ·         Organize, log and disperse all requests that come into CTMS DE mailbox.

    ·         Accountable for team SLAs, Metrics and Quality Control.

    ·         Run weekly team meetings and Lead meeting with Sponsor.

    ·         Act as a liaison between the Sponsor and team as well as provide feedback to Supervisor regarding team

    ·         Training and mentoring of staff.

    ·         Support special projects that are identified throughout the year that impact above responsibilities.

    Qualifications

    2 years of clinical data experience

    Bachelor’s degree



    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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