Clinical Study Start-Up Specialist

Job Summary:The Country Study Start-Up Specialist II will drive and execute clinical study start-up and maintenance activities for assigned studies and sites. This position focuses on site activation, essential document management, ethics and regulatory submissions, informed consent documentation, study tracking, and ensuring compliance with applicable clinical research regulations and guidelines. Key Responsibilities:• Execute study start-up and maintenance activities for assigned clinical studies and sites while ensuring quality and timely delivery.• Develop site activation plans, establish priorities, identify risks, and support mitigation strategies.• Collect essential site documents and perform quality checks in accordance with ALCOA principles.• Compile and submit ethics and other required local documentation packages.• Customize informed consent forms, patient-facing materials, and safety reporting documentation.• Coordinate regulatory submission and approval activities to support timely site activation.• Collaborate with study teams, contract managers, site monitors, regulatory teams, and other stakeholders.• Review site and Institutional Review Board or Ethics Committee comments on informed consent forms and coordinate required approvals.• Support clinical supply activities, investigational product release, shipment initiation, and site activation.• Track study start-up and maintenance activities within Vault Study Start-Up systems.• Maintain country and site intelligence information and essential document lists.• Track study start-up performance metrics and key performance indicators and provide updates to relevant stakeholders.• Maintain audit and inspection readiness and ensure compliance with applicable policies, regulations, and guidelines.• Participate in process improvement initiatives and support the training and mentoring of new study start-up specialists. Required Qualifications:• Bachelor’s degree, preferably in a healthcare or scientific field, or equivalent relevant professional experience.• Three to five years of clinical research experience.• Working knowledge of ICH and GCP guidelines.• Operational understanding of the applicable clinical research regulatory environment.• Experience coordinating clinical study activities across multiple stakeholders and priorities.• Strong interpersonal and communication skills.• Ability to work effectively with remote and virtual teams.• Ability to manage multiple priorities in a fast-paced clinical research environment. Preferred Qualifications:• One or more years of study start-up management experience.• Hands-on experience with clinical study start-up and site activation activities.• Experience with ethics committee or Institutional Review Board submissions and informed consent documentation.• Experience with Vault Study Start-Up or similar clinical study management systems.• Experience supporting regulatory submissions, essential document collection, and inspection readiness. Benefits:The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Pay Range: $50/hr to $60/hr