Study Start-Up Specialist II

hace 11 horas


San Cristóbal de las Casas, Chiapas, México Iqvia A tiempo completo

**Job Summary**

We are seeking a highly skilled Study Start-Up Specialist II to join our team at IQVIA. As a key member of our start-up team, you will be responsible for ensuring the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED), and Investigator Site Files (ISF) during the start-up process.

**Key Responsibilities**

  • Provide updates during weekly client teleconferences, client meetings, and internal team meetings.
  • Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, and other interdepartmental team members to enable a rapid clinical trial start-up.
  • May provide a role in the coordination of the development of the feasibility questionnaire for a study, reviewing the protocol and seeking expertise from applicable supporting functions.
  • Work with Project Managers to obtain client approval of the study-specific feasibility questionnaire, as needed.
  • May support the ISSC Lead/Manager in working with clients to obtain/agree to study-specific Confidential Disclosure Agreement (CDA) Templates.
  • May distribute CDAs and feasibility questionnaires to sites and follow up with sites accordingly to ascertain interest and meet study timelines.
  • May review and negotiate CDAs according to country-specific requirements, seeking legal/management review when required.
  • Sends regulatory packets to selected sites and documents/follows up with sites on the start-up process.
  • Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
  • Supports sites to answer any questions required for their local IRB/ethics committee submissions.
  • Serves as IQVIA Biotech liaison with Central Ethics Committees (CECs), Institutional Review Boards (IRBs), Research Ethics Boards (REBs), and Ethics Committees (ECs), as applicable.
  • May create, review, negotiate, and customize country/site-specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
  • Contacts sites directly, or through local representatives, as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
  • May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
  • Liaise with legal and internal teams to secure authorization of site contracts.
  • Coordinate document translations required for CEC/EC submissions, as needed.

**Requirements**

  • Strong understanding of regulatory compliance and clinical trial start-up processes.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office and other relevant software applications.


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