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Investigator Strategy and Site Coordination Associate (UK Homebased) - Novella Clinical (R1051597) in Stevenage, UK at IQVIA™

Date Posted: 12/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Stevenage, UK
  • Experience:
    Not Specified
  • Date Posted:
    12/5/2018
  • Job ID:
    R1051597

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Novella Clinical, A Iqiva Company, is a global full service CRO, committed to providing an outstanding service to our clients as well as our employees. We focus on providing excellent training and career development opportunities, encouraging growth from within our talented workforce.

Start-Up:

  • Supports the ISSC lead or representative to provide updates during weekly client teleconferences and internal team meetings, as required.
  • Participates in the drafting of the feasibility questionnaire for a study.
  • Assists in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines.
  • Participates in the review and negotiation of the CDAs according to country specific requirements.
  • Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process at the site. 
  • Supports sites to answer any questions required for their local IRB/ethics committee submissions.
  • Depending on the country, may support the review and negotiate Informed Consent Forms and follows up with sites and sponsors accordingly.
  • Contacts sites directly, or through local representative (country dependent), as required to resolve issues before IRB/ethics committee submission and final review.
  • Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
  • Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
  • Adheres to study timelines, documents/escalates study challenges, and communicates updates to Project Manager and ISSC Lead/Management.
  • Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study. 

    Ongoing File Maintenance:

  • Reviews documents received from sites, IRBs and CRAs to ensure compliance with GCP and Novella’s standard operating procedures. 
  • Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
  • Communicates directly with the site, or with local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents.  Tracks any action items to CRAs/sites in CTMS.
  • Reviews eTMF reports on a regular basis to ensure all documents have been filed according to Novella SOPs.
  • Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required. 
  • Supports the review of site specific ICFs as changes occur during the study.  Completes ICF checklists and files IRB approved ICFs throughout the study.  Maintains accurate and complete site specific ICF template tracking.
  • Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).
  • Submit ongoing regulatory documents to clients as needed.
  • Follows the appropriate Novella and/or sponsor SOPs during conduct of the study.
  • Ensures all project documentation is appropriately filed per Novella SOPs, or Sponsor SOPs if required.
  • Provides updates to ISSC manager on a regular basis, and communicates any out of scope activities.
  • Uploads final documents in eTMF.
  • Supports in creating study specific template documents, per Novella SOP.
  • Performs other duties as required.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1051597