FSP - Regulatory and Start-up Specialist

1 semana atrás

São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

Under moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.

Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.

Essential Functions

  • With moderate oversight and supervision, serve 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, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
  • 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.
  • Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

  • Bachelor's Degree Life sciences or a related field

  • 1 - 2 years of experience in a regulatory role in a CRO or pharma (not sites) 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.

This is a hybrid role.

Offices are located in Sao Paulo, SP.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more

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