Study Start Up Specialist

Brazil14h ago

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Skills

gcpproject management

About the role

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Study Start Up Specialist based in Brazil.

We are seeking a detail-oriented and proactive professional to support the successful initiation of clinical trials. In this role, you will coordinate essential study start-up activities, helping ensure clinical sites are activated efficiently and in compliance with regulatory requirements. You will collaborate with global study teams, regulatory stakeholders, and site personnel to facilitate documentation, submissions, and approvals. Your work will contribute to accurate project tracking, effective communication, and timely delivery of study milestones. This opportunity offers a collaborative, international environment where organizational skills and clinical research expertise make a meaningful impact. If you are passionate about clinical trial operations and advancing medical research, this role offers an opportunity to contribute to the development of potentially life-changing therapies.

Accountabilities

Coordinate day-to-day study start-up activities, ensuring deliverables are completed according to established objectives, timelines, and applicable Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and regulatory requirements.
Oversee site-level start-up activities, from initial site identification through activation, under the guidance of the Global Study Start-Up Manager.
Coordinate the collection of confidentiality disclosure agreements (CDAs), site questionnaires, and essential documentation required for site activation.
Manage informed consent form (ICF) negotiations, institutional review board (IRB) or ethics committee (EC) submissions, investigational medicinal product (IMP) release requirements, and other site activation deliverables.
Support the implementation of regional study start-up strategies and contribute to the consistent application of global processes, standards, and tools.
Prepare study-level essential document templates and assist with the preparation of regulatory submission materials.
Prepare and submit IMP release packages, ensuring all required documentation is accurate and complete.
Monitor and forecast site activation timelines, proactively identify potential delays or operational issues, and escalate concerns to the appropriate stakeholders.
Maintain accurate and up-to-date study information, project status reports, and financial data, where applicable, in relevant tracking systems and clinical platforms.
Build effective working relationships with internal teams, study stakeholders, site personnel, and contract staff to support successful trial execution.
Ensure adherence to applicable regulations, clinical trial guidelines, internal procedures, and quality standards throughout assigned activities.

Requirements

Bachelor's degree in a relevant field, or an associate degree combined with at least two years of experience in healthcare or directly related clinical trial activities.
Practical knowledge of clinical trial conduct and a general understanding of drug development processes.
Familiarity with ICH/GCP guidelines and applicable regulatory requirements for clinical research.
Proven project management skills, including the ability to coordinate multiple activities, monitor timelines, and manage competing priorities.
Strong administrative and organizational abilities, with excellent attention to detail and a commitment to accurate documentation.
Excellent written and verbal communication skills, with the ability to collaborate effectively with international teams and external stakeholders.
Computer proficiency and the ability to work confidently with clinical systems, tracking tools, and project management platforms.