Site Activation Expert

Há 7 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$90.000 - R$120.000
Job Title

FSP - Regulatory & Start Up Specialist

About the Role

The Site Activation Specialist will be responsible for executing feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. This includes preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites and sponsors, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, tracking completion of appropriate documents for sites, ensuring contracts are fully executed, and establishing project timelines.

Key Responsibilities
  • With moderate oversight and supervision, serve as a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions.
  • Prepare site documents, reviewing for completeness and accuracy.
  • Inform team members of completion of regulatory contractual and other documents for individual sites.
  • Distribute completed documents to sites and internal project team members.
  • Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
Requirements
  • Bachelor's Degree in Life Sciences or a related field.
  • 1-2 years of experience in clinical research regulatory and the following particular experience: CEP/CONEP - initial submission for Main Site and remaining sites, amendments to Main Site and Remaining sites, Notifications; ICF - Review and adaptation of local requirements (Country customization); ANVISA (MoH) - Initial DEEC Submission, Substantial Protocol Amendments, FAEC Update (Anvisa Clinical trial Form), annual study report (DEEC), Annual Safety Report (DDCM).
  • Advanced level of English skills.
  • Great communication skills and ability to work in a team.

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