Regulatory and Site Start-Up Specialist - Remote / Telecommute
Cynet Systems · United States · 3 wk ago
RemoteRemoteLegal$26.54/hrContract
Pay Range: $26.54hr - $31.54hr Job Overview Under general supervision, the candidate will perform feasibility, site activation, and maintenance activities in assigned studies for investigative sites according to applicable regulations, SOPs, and work instructions. The candidate will work closely with the Site Activation Manager (SAM), Project Management team, and other departments. Primary duties include reviewing site documents for completeness, consistency, and accuracy under the guidance of senior staff, preparing site documents, and informing team members upon completion of regulatory, contractual, and other individual site documents. Responsibilities 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.Conduct site identification and feasibility activities, regulatory, start-up, and maintenance activities.Prepare, review, negotiate, and manage 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 sponsors.Ensure tracking and 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 at the global, regional, or country level, and submit all relevant documents timely to the Trial Master File.Establish and execute goals and objectives for the team, as well as track and deliver on operational and financial performance.Participate in the broader global site activation planning process, contribute to long- and mid-range goals and plans, and coordinate activities with other managers. Candidate Profile Perform tasks at a country or region level associated with site activation activities under general supervision, in accordance with applicable local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.Possess 2+ years of experience in a healthcare environment or an equivalent combination of education, training, and experience.Function as an established individual contributor who delivers objectives that significantly impact results for a job area.Apply discretion within broad operational boundaries to analyze and resolve general problems. Education Bachelor s Degree in life science or a related field. Benefits Our Benefits Include: Medical, Dental, and Vision Insurance401(k) Retirement PlanHealth Savings Account (HSA)Disability Insurance (Short-Term and Long-Term)Life and AD&D InsurancePaid Sick Leave (where required by applicable state or local law)Supplemental Insurance PlansIdentity Theft ProtectionPet InsuranceEmployee Wellness ProgramsEmployee Assistance Program (EAP)Career Growth and Professional Development Opportunities Disclaimer: 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. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws. About Cynet Systems 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.