IHCRA

ICON

  • Paris
  • CDI
  • Temps-plein
  • Il y a 1 mois
OverviewICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.ResponsibilitiesWe are looking for motivated Clinical Trial Coordinator (CTA) based in the Paris/Ile-de-France area to join our sponsor dedicated CRA team!You will join a dynamic and engaging team of consultants, and you will have a dedicated line manager both at the client site and at ICON to support you throughout this journey.Trial and Site administration:
  • Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request
Document Management:
  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents
  • Assist with eTMF reconciliation
  • Updating manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Execute eTMF Quality Control Plan
  • Obtain translations of documents
Budgeting, Agreement and Payments:
  • Collaborate with finance/budgeting representatives for:
  • Develop country and site budgets (including Split site budget)
  • Tracking, and reporting of negotiations
  • Maintenance of tracking tools
  • Contract development, negotiation, approval and maintenance (e.g. CTRAs)
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Payment calculation and execution (investigators, vendors, grants)
  • Ensure compliance with financial procedures
  • Monitor and track adherence and disclosures
  • Budget closeout
  • Obtain and process FCPA documentation in a timely manner
Meeting Planning:
  • Organize meetings (create & track study memos/letters/protocols
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor
  • Contributes strongly to CTC team knowledge by acting as Subject Matter Expert
  • Mentors / buddies junior CTCs on process requirements
Qualificationsyou will need:
  • A minimum of 1 year of experience as CTA,CTC
  • Strong coordination and organizational skills
  • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
  • Fluency in French and in English
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
#LI-DC1
#LI-HybridVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles

ICON