Site Feasibility Specialist II
Buenos Aires, AR
hace 16 horas
source : DirectEmployers Association

Global Site Feasibility team is looking for a Specialist level 2, which will be responsible for following the approved processes for collecting Confidential Disclosure Agreements (CDA) and Feasibility Questionnaires (FQ) from sites around the globe.

This role will be home-based and this professional can be located into any country of Latin America region. Job responsibilities : + Supports the Site Feasibility Lead or representative to provide updates during weekly client teleconferences and internal team meetings, as required.

  • Liaise with Clinical Monitoring, Site Start Up Lead, Regulatory Affairs, other interdepartmental team members, and sponsor to enable a rapid clinical trial start-up.
  • May participate in the drafting of the feasibility questionnaire for a study.+ Will assist in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.
  • Participate in the review and negotiation of the CDAs according to country specific requirements.+ Adheres to study timelines, documents / escalates study challenges, and communicates updates to Project Manager and SSU Lead / Management.
  • Maintains quality and regulatory compliance among investigational sites during Site Feasibility.+ Maintains up to date and accurate tracking on the Site Feasibility status for each site in applicable system(s) for the study.
  • Liaise with team members to understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
  • Identifies out of scope activities to Site Feasibility Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
  • Responsible for transitioning sites from Site Feasibility to SSU representative.+ Provides updates to Lead / Manager on a regular basis and communicates any out of scope activities.
  • Required knowledge, skills and abilities : + Bachelor's in scientific, health care of related field.+ Knowledge of clinical research process related to study start-up and medical terminology.

  • Experience with Feasibility Questionnaires (FQ) and Confidential Disclosure Agreements (CDA).+ Working knowledge of current ICH GCP guidelines and applicable regulations.
  • Experience with client facing and global view perspective.+ Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
  • Excellent organizational and interpersonal skills.+ Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
  • Ability to manage multiple competing priorities within various clinical trials.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
  • The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

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