• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project. • Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned. • Serve as second reviewer for TMF QC. • May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight. • Assist with/complete end of study TMF filing (including site close out documents), QC and archival. • Further develop skills in preparing and participating in audit responses. • Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables. • Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned. • Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned. • Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable. • Assist with presenting final feasibility results to PM team and/or Sponsor. • Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).

Role Description The Clinical Site Startup Specialist plays a pivotal role in the successful initiation of clinical trials by overseeing and coordinating all activities related to site startup. This position involves meticulous management, tracking, and facilitation of processes, from site selection through the Site Initiation Visit (SIV) phase. The specialist will be responsible for ensuring seamless execution of various tasks, including: - Regulatory document collection - Site contract and budget negotiations - IRB submissions and approvals - Equipment provisioning - Completion of a comprehensive greenlight checklist for drug release As the owner of the site’s contract and budget, the clinical site startup specialist will also be responsible for processing any amendments that are needed to site budget or contract. Qualifications - Bachelor's degree in a relevant field (life sciences, healthcare, etc.) - Previous experience in clinical trial site startup or a related field (2 years preferred) - Strong negotiation and communication skills - Experience managing clinical trial site contracts and budgets - Detail-oriented with excellent organizational and time-management abilities - Ability to work collaboratively in a team-oriented environment - Knowledge of regulatory requirements and guidelines governing clinical trials - Excellent written, verbal and interpersonal communication skills - Must be willing to travel up to 10% of the time Requirements - Collect, review, and track all required regulatory documents from selected trial sites - Ensure compliance with regulatory standards and guidelines - Engage in negotiations with clinical trial sites for contracts and budgets - Collaborate with the clinical trial manager and legal and finance teams to finalize agreements - Execute amendments to contracts/budgets as needed - Prepare and submit central Institutional Review Board (IRB) application in collaboration with the site and study team - Track local IRB submissions and approvals - Facilitate communication between Perspective, sites and IRBs to obtain timely approvals - Coordinate the provisioning of necessary equipment at trial sites - Ensure that all equipment is compliant with trial protocols and regulations - Execute a comprehensive checklist for drug release in collaboration with relevant stakeholders - Confirm that all site startup activities are completed and meet the required standards before drug release - Maintain open communication with internal and external stakeholders - Collaborate with cross-functional teams to address challenges and ensure a smooth startup process - Maintain accurate and up-to-date records of all site startup activities - Generate reports for management and project teams as needed - File all essential documents in the study eTMF Benefits - Equal employment opportunities to all employees and applicants for employment - Prohibits discrimination and harassment of any type - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Build pipeline through outbound (LinkedIn, sequencing tools, events) • Engage senior stakeholders (e.g., Clinical Ops, Patient Engagement, Procurement) • Qualify opportunities using structured frameworks (e.g., MEDDIC) • Run the full sales cycle: discovery → demo → proposal → negotiation → contract • Navigate complex enterprise buying processes • Manage timelines, stakeholders, and forecasting in CRM • Build strong relationships with enterprise clients • Identify expansion opportunities (pilots → multi-country rollouts) • Represent Curewiki at industry events (4–6/year) • Work with Growth, Product, and Leadership on strategy and key accounts • Share market feedback to shape product and positioning

Review client charts to ensure quality service delivery and accurate treatment plans are in place, in addition to addressing complaints and resolving problems. Provide hands on leadership, supervision, and support to our clinical staff.