Job description

Job Overview

This role serves as the primary liaison with investigative sites throughout site start-up and maintenance processes, ensuring collection of all essential documents required for a clinical study. The specialist is responsible for coordinating timely submissions to Ethics Committees, Institutional Review Boards, Regulatory Authorities, and other relevant bodies in accordance with agreed timelines. They provide guidance on submission requirements, stay current with regulatory standards, and act as a subject matter expert within their country or region. Additionally, they mentor new or less-experienced team members as needed.

Key Responsibilities

Maintain up-to-date knowledge of regulatory legislation, guidance, and practices across assigned countries.
Coordinate the compilation of data and documentation for EC/IRB/Regulatory Authorities, including preparation of country-specific application forms and cover letters for sponsor approval.
Review and negotiate informed consent forms in collaboration with investigative sites.
Prepare and manage routine submissions (e.g., INDs, CTAs) to relevant review boards and regulatory entities, liaising as required.
Collaborate with internal and external vendors on Regulatory Authority submissions as applicable.
Review final submission documents to ensure accuracy and compliance.
Monitor all start-up and maintenance tasks for adherence to client expectations, budgets, legal and regulatory requirements, ICH/GCP guidelines, SOPs, and quality standards.
Identify and escalate study-related issues promptly and appropriately.
Serve as the main contact for investigative sites to ensure timely collection of required documentation.
Review, format, and compile documents with quality control to facilitate compliant site activation and maintenance.
Ensure all documentation and system records are consistently updated and audit-ready.
Participate in relevant team and project meetings.
Assist in defining strategies for site activation and provide accurate progress estimates and timelines.
Customize informed consent forms to ensure compliance with local regulations and protocols, resolving any related site issues proactively.
Support negotiation of site contracts and budgets where applicable, tracking progress and escalating concerns as necessary.
Notify Submission Leads of any risks to meeting deliverables or of out-of-scope hours.
For EU centralized roles, assist with uploading documentation to the Clinical Trials Information System (CTIS), monitoring alerts and milestones to ensure adherence to timelines.

Qualifications

Bachelor’s degree or college qualification preferably in life sciences, or certification in a related allied health field (e.g., nursing, medical technology) with at least 2 years of clinical research experience including strong knowledge of ICH guidelines and regulatory/ethics board requirements.
Alternatively, candidates with a high school diploma and a minimum of 2 years clinical research experience meeting the same knowledge criteria will also be considered.

Experience

At least 2 years of relevant experience in clinical development or regulatory/start-up processes.
Familiarity with ICH guidelines, regulatory authority, and IRB/IEC procedures, including start-up documentation and contract/budget negotiations.
Proven ability to understand research protocol requirements and communicate these effectively to teams and sites.

Work Environment and Physical Demands

The position is based in a standard office setting.

Compensation and Benefits

Salary range offered is $60,000 to $70,000 annually. Benefits for employees working 20+ hours weekly include medical, dental, vision, life insurance, disability coverage, 401(k), paid or flexible time off, and company bonuses where eligible. Offers consider experience, credentials, internal equity, and market data.

Application Details

Deadline for applications is August 10, 2026. The company supports equal employment opportunities and reasonable accommodations.

Study Start-Up Specialist