Clinical Project Assistant
CTI Clinical Trial and Consulting Services
há 6 dias
source : Ofertas de Emprego

Job Purpose / Summary

Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, and quality standards are being achieved.

What You’ll Do

  • Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project;
  • Provide support for site management activities to Clinical Project Manager / Director and CRA

    Maintain clinical project documents in paper and / or electronic Trial Master Files and perform TMF reconciliation and period review follow-up

    Prepare Investigator Site Files

  • Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications and plans;
  • distribute reports and communications to sites, vendors, Sponsors, and internal team members

  • Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others;
  • attend routine internal and external team meetings

    Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management

    Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities

    What You Bring

    General knowledge of medical and pharmaceutical terminology

    General knowledge of the drug development and clinical trial process

    General knowledge of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements

    Strong verbal and written communication skills

    Strong organizational and record retention skills

    Strong customer service and interpersonal skills

    Ability to successfully work within a team-based environment

    Ability to work independently with minimal oversight

    Proven ability to handle multiple tasks and manage time efficiently

    Strong computer literacy and proficient with Microsoft Office Suite

    Ability to quickly learn and adapt to new systems and technologies

    Why CTI?

    We support career progression 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward

    We value education and training We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department

    We value our people We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade

    Our culture is unparalleled Click here to learn more about The CTI Way

    We think globally and act locally We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our CTI Cares program)

    We are looking toward the future We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate

    Our work makes a difference We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

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