Startup Specialist (CTC-regulatory)

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

Resumo da oferta

An established industry player is seeking a Startup Specialist to oversee regulatory start-up activities. This role involves coordinating with investigative sites, ensuring compliance with local regulations, and maintaining high-quality documentation. You will be responsible for preparing submission documents and liaising with regulatory bodies, making this an exciting opportunity for those passionate about clinical research. Join a dynamic team and contribute to impactful projects in a supportive environment, where your expertise will help shape the future of clinical trials.

Qualificações

• 2+ years of clinical research experience in regulatory start-up processes.
• Knowledge of ICH guidelines and RA regulations.

Responsabilidades

• Coordinate and organize data for regulatory submissions.
• Ensure compliance with local regulations and sponsor specifications.
• Serve as primary contact for investigative sites.

Conhecimentos

Clinical Research

Regulatory Compliance

Document Management

Negotiation

Formação académica

University/College degree in life sciences

Relevant certification

Descrição da oferta de emprego

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Job Overview

Primary contact with investigative site(s) during site start-up activities and maintenance, responsible for collecting the required investigator and essential documents for a study. Ensure EC/IRB/Third body/Regulatory Authority and other local applications are made within the agreed timelines and meet regulatory and sponsor specifications. Proactively interact with authorities to provide guidance and maintain awareness of current standards. Serve as a local expert and mentor new or less experienced colleagues.

Summary of Responsibilities

• Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
• Coordinate, collect, and organize data and information required by authorities, including study documentation and applications.
• Prepare and liaise on submission documents to IRB/IEC/Third parties/regulatory bodies.
• Coordinate with vendors for regulatory submissions.
• Review final submission documents.
• Ensure start-up and maintenance activities are on track, compliant, and within budget.
• Escalate issues timely and perform additional duties as assigned.
• Serve as primary contact for investigative sites, ensuring timely collection and review of documents.
• Maintain high-quality documentation and system updates for audit readiness.
• Participate in meetings and assist in site activation strategies.
• Review and customize patient informed consent forms for local compliance.
• Support site contract and budget negotiations if applicable.
• Identify and escalate risks to meeting deliverables.
• Assist with CTIS tasks for EU submissions.

Qualifications (Minimum Required)

• University/College degree in life sciences or related field, or relevant certification, with 2+ years of clinical research experience.
• Knowledge of ICH guidelines, RA, IRB/IEC regulations.
• Relevant experience can substitute educational requirements.

Experience (Minimum Required)

• At least 2 years in clinical development or regulatory start-up processes.
• Knowledge of regulations, investigator documents, and negotiation processes.
• Ability to understand and communicate protocol requirements.

Physical Demands/Work Environment

• General Office Environment.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Legal