Site Activation Specialist in Brazil - Sao Paulo, Brasil - IQVIA

IQVIA

Empresa verificada

Sao Paulo, Brasil

há 2 semanas

Postado por:

Ana Silva

beBee Recruiter

Descrição

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