Regulation and Start-Up Specialist

Pay Range: $22.80/hr - $27.80/hr

Responsibilities

• Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory, contractual, and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
• Review, track, and follow up on the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release.
• Manage a team of employees responsible for executing site activation activities that may include site identification and feasibility activities, regulatory, start-up, and maintenance activities.
• Preparation, review, negotiation, and management of site regulatory documentation and clinical trial agreements with sites and sponsors.
• Maintain, review, and report on site activation performance metrics.
• Serve as the primary point of contact for investigative sites and/or sponsors.
• Ensure tracking completion of all regulatory and contractual documents for sites.
• Establish project timelines.
• Ensure all site activation activities are performed in accordance with all regulations, SOPs, Work Instructions, and project requirements.
• Establish and/or execute goals and objectives for team(s) as well as tracking and delivering on operational/financial performance.
• Participate in the broader Global Site Activation planning process; contribute to long-mid range goals and plans; and coordinate activities with other managers and their respective sub-families.

Requirements

• 2+ years of experience in a healthcare environment or equivalent combination of education, training, and experience.
• Strong verbal and written communication skills.

Qualifications

• Bachelor's Degree in life science or related field.

Benefits

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates.

About the Company

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia. As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.