Site Navigator - Start Up Specialist - For Portugal

Fortrea; São Paulo; Presencial; BRL 30.000 - 70.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Site Navigator - Start Up Specialist to join their team in Brazil. This role involves serving as a local expert in project start-up activities, including site identification and feasibility assessments. The ideal candidate will have a minimum of 2 years in clinical development, showcasing their ability to negotiate contracts and budgets effectively. Join this dynamic team and contribute to impactful clinical research initiatives while ensuring compliance with local regulations and guidelines. This is a fantastic opportunity to grow your career in a supportive environment that values expertise and collaboration.

Qualificações

• Minimum 2 years in clinical research with knowledge of ICH and RA regulations.
• Experience with contract negotiations and site identification preferred.

Responsabilidades

• Coordinate essential documents for regulatory authorities as per guidelines.
• Serve as primary contact for investigative sites, ensuring timely document collection.

Conhecimentos

Clinical Development

Regulatory Processes

Contract Negotiation

Feasibility Assessment

Site Identification

Formação académica

University/College Degree in Life Sciences

Relevant Certification

Descrição da oferta de emprego

Site Navigator - Start Up Specialist - For Portugal

Join Fortrea as a Site Navigator - Start Up Specialist for Portugal! Serve as a local expert in project start-up activities.

Responsibilities

• Site identification experience and feasibility assessment (preferable)
• Contract and budget negotiation with sites (minimum 1 year, preferably in Portugal)
• Coordinate, collect essential documents, and organize data for EC/Third body/Regulatory Authority according to local legislation and guidelines
• Remote PSV experience (preferable)
• Serve as primary contact for investigative sites, ensuring timely collection of required documents

Experience Required

Minimum of 2 years in clinical development, start-up, or regulatory processes.

• Knowledge of ICH, RA, IRB/IEC regulations and guidelines
• Familiarity with investigator start-up documents and contract/budget negotiations
• Experience working with operational project teams and investigative sites
• Understanding research protocol requirements and ability to communicate and educate about them

Qualifications (Minimum)

• University/College degree (life sciences preferred) or relevant certification with 2 years' clinical research experience, including knowledge of ICH, RA, IRB/IEC regulations
• Relevant experience may substitute educational requirements

Additional Information

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Seniority level

• Entry level

Employment type

• Full-time

Job function

• Other, Information Technology, Management