Study Start-Up Specialist

Study Start-Up Specialist The Study Start-Up Specialist (SSUS) plays a pivotal role in supporting timely site activation and regulatory readiness across assigned clinical studies. This role is responsible for managing site start-up activities, coordinating IRB submissions, and ensuring essential documentation is complete, accurate, and inspection ready. The Specialist works cross-functionally with project management, all Clinical Operations functions, QA, CRAs, and Sponsors to enable efficient study start-up and reduce downstream operational risk. Essential Duties and Responsibilities Regulatory Compliance Prepare, compile, and submit clinical trial applications to ethics committees, as applicable. Assemble and maintain submission dossiers, including managing responses to ethics committee queries Track submission timelines and approval status using applicable tools and internal trackers. Coordinate customization and site-specific adaptations of informed consent forms (ICFs) and patient information sheets. Site Start Up & Activation Develop and execute detailed, study-specific start-up plans for assigned sites. Track site activation milestones and timelines using study-specific tools and trackers. Create, collect, review, and track essential documents for site activation. Ensure start-up documents are complete, compliant, and inspection ready. Identify risks to activation timelines and proactively escalate to study leadership. Schedule and coordinate start up meetings, including agendas and minutes as needed. Contracts, Budgets & Cross Functional Collaboration Participate in site contract and budget discussions in collaboration with Contracts and Finance teams. Partner closely with CRAs/CTMs/PMs to ensure consistent and aligned communication with sites during the start-up phase. Serve as a primary point of contact for sites during start-up, providing clear guidance on expectations and timelines. Collaborate with internal stakeholders to resolve start-up issues and maintain momentum toward activation. Documentation and Quality Maintain accurate, up-to-date documentation for the TMF and applicable study systems. Ensure compliance with protocol, SOPs, GCP, and applicable regulatory requirements, as well as study trackers. Support internal reviews, audits, and inspections related to start-up and regulatory activities. Assist continuous improvement of start-up and site activation processes. Assist with preparation of internal and sponsor-facing status reports Feasibility and Site Tracking Support feasibility activities by tracking site level information, including: Securing NDA/CDA from a site prior to sending study related materials PI and site experience Rater availability and experience Patient population access Competitive trial landscape. Maintain feasibility trackers; update site intelligence based on outreach, assessments, and site feedback. Assist in evaluating site readiness and capacity to support enrollment goals. Provide feasibility insights to CTMs, CRAs, and project management as requested. Audit and Inspection Readiness Ensure start-up documentation is inspection-ready at all times. Support internal TMF reviews and quality checks, addressing gaps in collaboration with CRAs and study teams. Assist with preparation for sponsor auditsand internal quality reviews. Respond to audit findings and support CAPA development related to start-up or regulatory processes. Ensure traceability between IRB submissions, approvals, and site activation documentation. Perform other duties as assigned in support of departmental needs. Qualifications Bachelor’s degree in life sciences, healthcare, or related field (or equivalent education, training and experience). Two years of experience in clinical research, , site start-up, or clinical operations, or an equivalent combination of education and experience. Preferrably with some CRO experience. Experience and knowledge of clinical start up process and requirements. Working knowledge of psychological assessments preferred. Working knowledge of clinical research regulations, including ICH-GCP and CFR. Ability to work independently with minimal supervision. Strong organizational skills and team player. Able to multitask and prioritize high workloads across multiple sites. Strong computer skills including but not limited to proficiency with Microsoft Office (Word, Outlook, and PowerPoint) and project management software (i.e., Monday.com ); proficiency with Excel (e.g., creating and managing formulas; use of macros, pivot tables, and v-lookup; etc.) Strong written and verbal communication skills; ability to communicate effectively with a wide variety of stakeholders in a professional manner via different means of communication (i.e., face to face, on the telephone, email, etc.). Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide effective customer service, and foster positive working relationships with internal and external stakeholders Excellent attention to detail, including problem solving and decision-making skills Able to work accurately to identify, analyze, prevent, and solve issues. Ability to travel <10% Department Clinical Operations Role Study Start-Up Specialist Locations Remote, US Remote status Fully Remote Employment type Full-time About Cognitive Research Corporation Cognitive Research Corporation (CRC) is a leading full-service contract research organization, specializing exclusively in CNS disorders. Guided by a commitment to urgency, consistency, and accuracy, we help bring new therapies through rigorous testing to FDA approval, ultimately improving patient outcomes.