Senior Clinical Operations Specialist

hace 2 días


Xico, México Parexel A tiempo completo
Job Description

The Senior Clinical Operations Specialist is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. This role may span over multiple countries depending on the geographical region and business needs.

Key Responsibilities
  • Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site initiation
  • Provide support to resolve issues or concerns and timely escalation of site issues where applicable
  • Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
  • Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements
Clinical Trials Conduct
  • Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct
  • Ensure maintenance of IRB/Ethics and other committees' activities as applicable
  • Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness
Communication
  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
  • Provide functional updates on a country and site level as required
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals

Estimated salary: $80,000 - $110,000 per annum, based on location and experience. The actual salary may vary depending on factors such as qualifications, skills, and performance. Benefits include competitive compensation, comprehensive health insurance, paid time off, and opportunities for professional growth and development.



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