Country Start-up Specialist – Maintenance

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

📋 Description

• Accountable for delivering quality outcomes at the national level while ensuring adherence to project specifications and relevant country regulations.

• Monitor submission and approval schedules along with milestone advancements in the SSU tracking system.

• Analyze delays, offer explanations, assist in contingency planning, and escalate issues as necessary.

• Oversee fundamental project financial elements and contracted hours/tasks.

• Review and adhere to SOPs and Work Instructions, maintaining records of training and timesheet compliance.

• Foster quality enhancements across country-specific Site Start-Up elements.

• Submit pertinent documents to the Trial Master File.

• Prepare and file applications for Central EC, Local EC, RA, regulatory authorities, and hospital approvals.

• Manage ongoing submissions, amendments, periodic notifications, safety alerts, and renewals.

• Act as a liaison between investigational sites and functional leaders, ensuring comprehensive site activation oversight.

• Maintain knowledge of country-specific regulatory information and provide support for data protection guidelines.

• Contribute to local SOPs, Work Instructions, and internal training resources.

• Assist in resolving issues with EC or Competent Authorities.

• Provide support for site selection and feasibility assessments.

• Aid in the development of country template contracts and budgets, negotiate site-specific contracts and budgets, conduct quality control, arrange CTA execution, and archive documents.

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

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

⛳️ Requirements

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

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

• Experience in supporting study maintenance tasks, including protocol amendments, continuing reviews, safety submissions, renewals, and ongoing regulatory compliance.

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

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

• Excellent project management and organizational capabilities.

• Strong written and verbal communication as well as interpersonal skills.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition among peers and a comprehensive rewards program.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company matching for 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.