Study Start Up Specialist

FTBRL Fortrea Brazil Limitada; São Paulo; On-site; BRL 180,000 - 300,000; Full time

Job summary

Fortrea Brazil Limitada is seeking a Regulatory Start-Up/SSU Associate to support day-to-day SSU operations in São Paulo. You will coordinate with study teams and stakeholders to achieve timely site activations under ICH/GCP guidelines, manage ICF negotiations, regulatory submissions, and IMP release packages, while maintaining accurate data in clinical systems.

Applicants should have a BS/BA or Associate degree with clinical trial exposure, strong project management, and excellent English

Qualifications

• Requires proven project management skills.
• Advanced/Fluent in English.
• Experience in health care or direct clinical trial related experience.

Responsibilities

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Generate and provide accurate and up-to-date project status and financial information within relevant tracking systems/tools.
• Proactively identify and elevate issues related to SSU deliverables.
• Lead the execution of assigned SSU activities.
• Support implementation of standards for the global SSU team.
• Oversee site level SSU activities from receipt of potential site list to activation under direction of Global SSU Manager.
• Implement the SSU Strategy for assigned region during the study start up period.
• Build relationships with internal counterparts and site staff to support activation strategies.
• Project site activation timelines and escalate when timelines slip.
• Adhere to processes and tools for SSU day-to-day activities.
• Lead the preparation of study level essential document templates.
• Aid in preparing content for Regulatory submissions.
• Handle ICF negotiations and escalations as required.
• Prepare and submit IMP Release Packages.
• Maintain accurate and timely information in relevant clinical systems.
• Ensure compliance with regulations and guidelines in support of assigned trials.

Skills

Project management

Interpersonal skills

Written communication

Verbal communication

Administrative skills

Computer skills

English fluency

Education

BS/BA degree or Associates degree with ≥2 years in health care or clinical trials

Job description

Summary of Responsibilities

Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools Proactively identify and elevate issues that arise related to support SSU deliverables Effectively execute against assigned activities within SSU Support implementation of standards for global SSU team This may include: Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements Implementation of the SSU Strategy for assigned region during the study start up period Building relationships with internal counterparts and site staff to support successful site activation strategies Projecting site activation timelines and appropriately escalating when things get off track Adhering to process and tools designed to the support of the SSU team with day-to-day activities Leading the preparation of study level essential document templates Aiding in the preparation of content for Regulatory submissions Handling ICF negotiations and facilitating any required escalations Preparation and submission of IMP Release Packages Maintaining accurate and timely information in relevant clinical systems Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.

Qualifications (Minimum Required)

BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience. Must have knowledge of clinical trial conduct General knowledge of drug development and ICH/GCP guidelines Requires proven project management skills Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Advanced / Fluent in English. Minimal (0-5%) travel required

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.