Start Up Specialist, FSP

In this role, you will manage end-to-end site start-up activities while ensuring compliance with regulatory requirements and study timelines. You will be responsible for maintaining accurate documentation and supporting effective communication between all stakeholders involved in clinical trial activation.

• Serve as the primary contact for investigative sites during start-up and maintenance activities, ensuring timely collection of essential regulatory and investigator documents
• Coordinate, prepare, and review submissions to IRBs/IECs and regulatory authorities, including study applications, informed consent forms, and related documentation
• Ensure all submissions and site activation activities comply with applicable regulations, ICH-GCP guidelines, sponsor requirements, and internal SOPs
• Track, manage, and maintain high-quality documentation systems to ensure audit readiness at all times
• Collaborate with internal teams, vendors, and external regulatory bodies to support submission processes and resolve issues proactively
• Identify risks, escalate issues appropriately, and support resolution to ensure study timelines and deliverables are met
• Support contract and budget tracking activities and assist in site activation strategy and planning when needed

Requirements

The ideal candidate brings strong clinical research experience with a solid understanding of regulatory start-up processes and site activation workflows. You are detail-oriented, organized, and confident working in a highly regulated, deadline-driven environment.

• Bachelor’s degree in life sciences or related field, or equivalent clinical/healthcare certification, or relevant experience in lieu of degree
• Minimum of 2 years of experience in clinical research, including exposure to site start-up and regulatory processes
• Strong knowledge of ICH-GCP guidelines, IRB/IEC processes, and regulatory authority requirements
• Experience working with clinical trial documentation, informed consent forms, and site activation deliverables
• Familiarity with Canadian and/or US site processes is strongly preferred
• Excellent organizational, communication, and multitasking skills with the ability to manage multiple studies simultaneously
• Strong problem-solving skills and ability to proactively identify and escalate risks
• Ability to work collaboratively with cross-functional teams, sites, and external stakeholders
• Previous experience in clinical operations or regulatory submissions is highly valued

Benefits

• Competitive annual salary range of $67,000 to $70,000 USD
• Remote work flexibility within the United States
• Opportunity to contribute to life-saving clinical research and global healthcare innovation
• Exposure to international clinical trial processes and regulatory environments
• Collaborative, mission-driven work culture focused on quality and patient impact
• Career development opportunities within clinical operations and regulatory functions
• Engagement with cross-functional global teams across clinical research programs.