Central Review Coordinator

Livingston, null, gb
Company: PRA Health Sciences
Category: Community and Social Service Occupations
Published on 2021-06-15 06:00:41

Overview

We don’t tell our employees what they should care about. They tell us.

At PRA, Philanthropy, charitable giving and social responsibility are more than buzz words for us – they’re ideas we hold up as ideals. Our passion and commitment to improving lives extend far beyond our work and we believe that it is our obligation to empower our employees to find meaningful ways to respond to the needs of others around the world.

Responsibilities

This role as Central Review Coordinator offers the right candidate the opportunity to join PRA’s Central Review Services team; unique in the CRO industry. The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and data management for SLE clinical and laboratory endpoints including: BILAG; SLEDAI; SLEDAI Flare Index; SLICC; and other assessment tools. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.

Responsibilities in the position will include:

  • Create and maintain Study Trackers.
  • Monitor screening deadlines; follow up with sites on data entry and other vendor data entry and escalate any visits that are not released for CR review or where queries are not being addressed within the timelines.
  • Review and determine on study visits and sweeps are ready for review using the page status and query reports.
  • Create, send and process assignments to reviewers, including query tracking.
  • Download and compile files for the patient profile creation and post on the Central Grading Portal for the Data Programmer, CRS.
  • Create internal CRS agenda and meeting minutes for distribution
  • Action/Decision log updates/maintenance
  • Filing of documents in Central Grading Portal and eTMF.
  • Liaise with Directors, Therapeutic Expertise, PRA internal team members and Sponsors.
  • Performs proficient reviews of study datasets prior to client transfer, if applicable.
  • Monitor review progress to meet timelines, identify issues, risks, possible solutions & report to Lead Central Review Manager.
  • Participates in database lock activities.
  • Serve as CR Coordinator on more or more projects.
  • Other duties as assigned.
  • Location: UK

    Qualifications

    Life Science degree qualified, driven by quality, a strong communicator and show initiative.

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through continued training, development and support. To be successful in this position you will have:

  • BSc Life Science degree with solid experience working within a CRO and or the pharmaceutical industry
  • Prior experience as a Data Coordinator
  • Strong experience with at least one of the data management systems
  • Experience in most study tasks
  • Comfortable working within a project team and have excellent written and verbal communication skills
  • Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

    For more information please visit our website: www.prahs.com

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