Role Description At Cogstate, we’re seeking an Associate, Raters Services (Clinical Trial Associate) responsible for supporting multiple tasks and functional areas to ensure the timely delivery of the Cogstate Rater Training Program. The Associate will serve as a liaison between the following groups and the training contacts designated by the program sponsor: - Scale Management (procurement and distribution of materials) - Clinician Network (quality and consistent delivery of global clinical interviews) - Science (creation of study content, scientific study oversight) - Site Training and Monitoring activities (training deployment, management, and in-study reporting/calibration) - Additional functional areas as deemed necessary during the clinical trial program The Associate is responsible for study reporting, maintaining successful relationships with the study sites/raters/CRAs/sponsors, and delivering quality management and oversight for all assigned clinical trial programs. Key Responsibilities - Manage and execute tasks in line with company SOPs and agreed regulatory standards, including: - Accurate record keeping of all tasks (real-time updates to applicable trackers and maintenance of high-volume emails/site communications) - Follow study changes, re-prioritize assignments based on study needs, and work independently - Mentor junior study team members and oversee their work output - Support activities of Rater Services Managers with minimal oversight on assigned tasks - Act as primary point of contact for sites/raters/CRO from study start-up through close-out - Drive activities and ensure timely delivery of project tasks leading to the completion of client deliverables - Direct communication with site level staff to provide operational support throughout the study lifecycle - Management and delivery of phase I-III clinical trials (understanding and tracking against the project SOW) - Effectively manage, track, and communicate key project deliverables in a proactive manner to the study PM or sponsor or Rater Training Lead - Assume a Rater Training Lead role for small to medium size studies - Coordinate consultant (LEAD) communications and scheduling Qualifications - Bachelor's degree and/or 3+ years of relevant experience - 2+ years’ work experience related to clinical trials - CRA/CRO experience is a plus - Project Management or service-related industry experience preferable - Ability to multi-task, being highly organized and methodical, with attention to detail - Strong people skills within the team and with customers and third-party providers - Demonstrated ability to learn quickly, work independently, plan and be proactive - Strong level of computer literacy (experience working with clinical software preferable) - Ability to thrive in a fast-paced, growing environment - Nice to have: fluency in an additional language in addition to English Requirements - People skills: within the team, and with customers and third-party providers, strong desire to learn, to seek feedback on performance and to learn quickly - Communication skills: both written and oral, providing operational support and conflict resolution - Work skills: eye for detail, problem solving, compulsion to check and double-check work product, ability to work fast, impeccable record keeping and compliance to procedures, high level of computer literacy (Excel/Office savvy) - Good organizational skills: handling multiple tasks, establishing and managing competing priorities, ability to work independently and to be proactive Benefits - Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom! - Company sponsored Private Medical Insurance through Vitality - 10% company contribution to pension plan - Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position - Learning & Development Opportunities: Cogstate offers a variety of learning and development opportunities from internal and external sources focused on leadership, and professional & personal development

• Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements; • Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; • Serves as a point of contact for CRAs and Lead CRAs for assigned projects; • Provides mentoring/oversight of CRAs and Lead CRAs; • Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; • Contributes to the development of the Clinical Monitoring Plan; • Prepares and conducts project-specific training for the CRAs; • Develops the annotated site visit reports and monitoring tools such as source data verification worksheets; • Conducts quality control visits with CRAs; • Coordinates and leads CRA meetings; • Performs co-monitoring visits with CRAs; • May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).

• Partner with research site staff to streamline and support activation, accrual, ongoing operations, and close-out activities for assigned clinical research studies. • Draft and refine essential clinical study documents, including project plans, protocols, informed consent forms (ICFs), and site-facing operational resources. • Generate and manage concept documents for IRBs, imaging oversight committees, grant applications, and business proposals. • Lead protocol team operations by managing regular calls, distributing action-oriented minutes, coordinating protocol amendments, and facilitating site educational sessions. • Manage and track all assigned project deliverables, providing regular metrics and progress reports to leadership and external stakeholders. • Guarantee that all study activities and documentation strictly adhere to Good Clinical Practice (GCP) guidelines and the Code of Federal Regulations (CFR).

• Responsible for the timely and accurate preparation and maintenance of budget templates for sponsored clinical trials • Review of New Study routing forms and essential study start-up documents • Itemized cost analysis and interpretation of clinical protocols into budgets milestones • Provide accurate patient cost descriptions for the ICF to be submitted to the IRB • Update budget, milestones, and ICF information as necessary per contract/protocol amendments • Manage large volume workflow across multiple research programs