Country Start-Up Specialist

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Accountable for ensuring high-quality deliverables at the country level while adhering to project specifications and relevant national regulations.

• Monitor submission and approval timelines through the designated SSU tracking system, and investigate or escalate any delays in timelines.

• Oversee basic financial elements of the project and track contracted hours and tasks.

• Review and adhere to Standard Operating Procedures (SOPs) and Work Instructions, maintain training records, and ensure compliance with timesheet submissions.

• Assist in enhancing quality across the Site Start-Up components at the country level.

• Submit pertinent documents to the Trial Master File.

• Prepare and file applications for central and local ethics committees, regulatory authorities, and other local approvals.

• Handle ongoing submissions, amendments, periodic notifications, safety alerts, renewals, and other regulatory maintenance tasks.

• Act as a liaison between investigational sites and functional leads, managing site activation from start to finish.

• Serve as a country-level Site Start-Up subject matter expert and maintain up-to-date regulatory knowledge.

• Provide support for data protection guidelines, local SOPs, work instructions, and internal training resources.

• Aid in resolving issues with ethics committees or competent authorities.

• Assist with site selection and feasibility studies.

• Facilitate negotiations regarding investigator contracts and budgets, contract execution, quality control, archival processes, and metadata capture.

• Coordinate country start-up initiatives from the award of the study through to site activation.

• Provide ongoing support to sites throughout the study lifecycle to ensure regulatory compliance and operational readiness.

⛳️ Requirements

• Experience in Clinical Research, Study Start-Up, Regulatory Affairs, Clinical Operations, or related areas.

• A Bachelor’s degree is required.

• Proven experience in managing country start-up processes, including regulatory and ethics committee submissions, essential document gathering, and study activation.

• Familiarity with study maintenance tasks, including protocol amendments, continuing reviews, safety submissions, renewals, and maintaining ongoing regulatory compliance.

• Strong grasp of ICH-GCP guidelines and local regulatory standards.

• Experience collaborating with various stakeholders, such as sponsors, CROs, investigator sites, and regulatory bodies.

• Exceptional project management and organizational abilities.

• Excellent written and verbal communication and interpersonal skills.

• Equivalent experience, skills, and/or education may be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Company-provided car or car allowance.

• Medical, dental, and vision health benefits.

• Company-matched 401k plan.

• Potential to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave provisions.