Study Start Up Specialist

Fortrea; São Paulo; On-site; BRL 90,000 - 120,000; Full time

Job summary

Fortrea in São Paulo seeks an SSU Operations Specialist to support day-to-day site start-up activities and ensure timely completion per GCP/ICH guidelines. You will coordinate with study teams, manage essential document templates, and assist with ICF negotiations and IRB submissions.

The role requires strong project management, excellent English communication, and the ability to work with cross-functional stakeholders. Some travel may be required as part of site activation efforts.

Qualifications

• BS/BA degree or Associate’s degree with 2 years of clinical trial or health care experience.
• Proven knowledge of ICH/GCP guidelines and clinical trial conduct.
• Excellent written and verbal English communication skills.

Responsibilities

• Support day-to-day SSU operations to meet study goals in compliance with GCP/ICH guidelines.
• Coordinate with study teams and stakeholders to enable timely site activation and regulatory submissions.
• Prepare and maintain study level essential document templates and content for regulatory submissions.
• Assist with ICF negotiations, CDA collection, IRB/EC submissions, and IMP release packages.
• Maintain accurate information in relevant clinical systems and escalate issues as needed.

Skills

Project management

Interpersonal skills

Written communication

Verbal communication

Education

BS/BA degree

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 escalate 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 requirementsImplementation of the SSU Strategy for assigned region during the study start up periodBuilding relationships with internal counterparts and site staff to support successful site activation strategiesProjecting site activation timelines and appropriately escalating when things get off trackAdhering to process and tools designed to the support of the SSU team with day-to-day activitiesLeading the preparation of study level essential document templatesAiding in the preparation of content for Regulatory submissionsHandling ICF negotiations and facilitating any required escalationsPreparation and submission of IMP Release PackagesMaintaining accurate and timely information in relevant clinical systemsResponsible 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 requiredPlease, submit your English resumeLearn more about our EEO & Accommodations request here .