FSP Regulatory and Start-up Specialist

Under moderate supervision the Site Activation Specialist executes the feasibility site identificationregulatory start-up and maintenance activities in accordance withregulations 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
Bachelors 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.

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