Study Start Up Specialist

Jobgether; Brasil; On-site; BRL 120,000 - 180,000; Full time

Benefits offered by this job

Remote work arrangement

Full-time employment

International exposure

Contribute to clinical research

Job summary

Jobgether is seeking a Study Start Up Specialist in Brazil to coordinate site activation, regulatory submissions, and essential site documentation for clinical trials.

You will partner with global study teams, regulatory stakeholders, and site staff to ensure GCP compliance, timely milestones, and accurate project tracking in an international, collaborative environment.

Qualifications

• Bachelor's degree (or associate) with clinical trial experience.
• Solid knowledge of clinical trial conduct and drug development basics.
• Familiarity with ICH/GCP and regulatory requirements.
• Proven project management, timelines, and priority handling.
• Strong documentation and organizational abilities.
• Excellent written and verbal communication for global teams.
• Proficiency with clinical systems and tracking tools.
• Advanced English proficiency required.
• Ability to work independently and escalate complex issues.
• Willingness to travel 0–5%.

Responsibilities

• Coordinate day-to-day study start-up activities per timelines and GCP/ICH requirements.
• Oversee site-level start-up from identification to activation.
• Coordinate CDA, site questionnaires, and essential activation docs.
• Manage ICF negotiations, IRB/EC submissions, and IMP release needs.
• Support regional start-up strategies and global process alignment.
• Prepare study-level documents and regulatory submission materials.
• Prepare and submit IMP release packages with complete documentation.
• Monitor activation timelines and flag delays to stakeholders.
• Maintain study information and status in tracking systems.
• Build relationships with internal teams, sites, and contractors.
• Ensure compliance with regulations, procedures, and quality standards.

Skills

Clinical trial conduct

Regulatory submissions

IRB/EC submissions

Project management

Documentation control

Communication skills

Computer literacy with clinical tools

English proficiency

Independent work

Travel readiness

Education

Bachelor's degree or Associate + 2 yrs trial exp

Job description

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 elevate 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.
• Advanced or fluent English proficiency is required.
• Ability to work independently, identify potential risks, resolve routine issues, and elevate complex matters appropriately.
• Willingness to travel occasionally, with an estimated travel requirement of 0–5%.

Benefits

• Remote work arrangement.
• Full-time employment.
• Opportunity to contribute to clinical research and the development of therapies that may improve patient outcomes.
• Exposure to international clinical trial operations and collaboration with cross-functional, global teams.
• Opportunities to develop expertise in study start-up processes, regulatory compliance, and clinical project coordination.