• Supports and demonstrates IMA’s core values • Values and understands the importance of diversity, equity, and inclusion among all IMA associates. • Execute basic certificate reviews with low complexity, ensuring accuracy and completeness. • Gains proficiency in key systems, including Outlook, Teams, SharePoint, TrustLayer, and myCOI. • Develop effective time management skills to meet deadlines and efficiently prioritize tasks. • Consistently complete all assigned tasks with a focus on meeting departmental turnaround times and quality standards. • Performs the essential functions of the role within an IMA office environment 0-50% of the time.

Role Description We are seeking a highly organized, detail-oriented, and collaborative Clinical Trial Assistant (CTA) to support the execution of clinical studies across our gene therapy development programs. Reporting to the Clinical Operations team, the CTA will provide operational, administrative, and systems support for clinical trials conducted in accordance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements. This role will partner closely with Clinical Trial/Program Managers, Clinical Operations, Data Management, Regulatory Affairs, Quality, vendors, CROs, and clinical sites to support study execution activities, documentation management, vendor coordination, and inspection-ready clinical operations processes. The ideal candidate is proactive, adaptable, and excited to contribute within a fast-paced biotechnology environment focused on advancing transformative genetic medicines for patients. Key Responsibilities - Provide operational and administrative support for global clinical studies across multiple gene therapy programs and study phases. - Support Trial Master File (TMF) management activities, including document collection, quality review, filing, reconciliation, and maintenance of inspection readiness. - Assist with clinical study start-up, maintenance, and closeout activities, including site documentation tracking, essential document management, investigator file support, and study communications. - Coordinate clinical meetings, including agenda development, meeting logistics, action item tracking, and preparation of meeting minutes. - Support vendor and CRO oversight activities, including tracking deliverables, invoices, contracts, purchase orders, and operational documentation. - Maintain clinical trial trackers, dashboards, study plans, timelines, enrollment reports, issue logs, and operational metrics. - Assist with investigator meeting planning, site training logistics, vendor meetings, and internal cross-functional study meetings. - Support regulatory and ethics submission preparation by coordinating required documentation and ensuring timely completion of deliverables. - Collaborate cross-functionally with Clinical Operations, Regulatory, Data Management, Safety, Quality, Medical Writing, and external partners to support efficient study execution. - Maintain clinical systems and databases, including CTMS, eTMF, document repositories, training records, and study-related operational tools. - Track study-related activities, deadlines, training assignments, and compliance requirements to support high-quality clinical trial execution. - Contribute to SOP development, process improvements, template management, and continuous operational excellence initiatives within the Clinical organization. - Ensure activities are conducted in compliance with GCP, applicable regulations, company policies, and quality standards. Qualifications - Bachelor’s degree in life sciences, healthcare, biology, nursing, public health, or related discipline preferred. - 1–4 years of experience supporting clinical research, clinical operations, pharmaceutical, biotechnology, CRO, academic research, or healthcare environments. - Experience supporting clinical trials or clinical operations activities strongly preferred. - Knowledge of clinical research regulations, ICH-GCP guidelines, clinical trial processes, and essential clinical documentation preferred. - Experience working with clinical systems such as CTMS, eTMF, Veeva Vault, Trial Interactive, Medidata, or related platforms preferred. - Strong organizational, project coordination, and multitasking skills with exceptional attention to detail. - Excellent written, verbal, and interpersonal communication skills. - Strong proficiency with Microsoft Office Suite (Excel, Word, Outlook, PowerPoint) and collaborative business tools. - Ability to manage multiple priorities and adapt effectively within a dynamic, fast-paced biotech environment. Additional Valued Qualifications - Experience in gene therapy, rare disease, neurology, oncology, cell therapy, biologics, or advanced therapeutics environments preferred. - Prior experience supporting outsourced clinical trial models and working with CROs, vendors, and clinical sites. - Exposure to global clinical studies and regulatory inspection readiness activities preferred. - Experience in emerging biotechnology or growth-stage life sciences companies preferred. Benefits - Comprehensive benefits package, including competitive employer premium contributions. - Meaningful stock option grants. - PTO, sick time and holiday pay. - Generous Parental Leave program. - Pre-tax medical and dependent care programs. - STD, LTD, Life and AD&D. - Professional development opportunities. - Team-building events. - Fully stocked micro-kitchen. - Fitness center at South San Francisco location.

• Conduct research on market trends, regulatory updates, and competitor payment product features relevant to BPay • Assist in preparing internal reports, dashboards, and data summaries for weekly reviews and stakeholder updates • Support documentation of operational processes, SOPs, and compliance checklists • Help track and follow up on open action items, task updates, and process improvement tickets • Coordinate minor cross-team requests and fill in operational process updates as directed • Assist with data gathering and formatting for compliance and ops audits

• Execute and manage regulatory submissions across primary, secondary, and external testing labs; track lab turnaround times and provide monthly metrics on submission volume and total testing costs. • Own and enforce the change management process for all platform changes requiring regulatory notification or approval; maintain accuracy of regulated change repositories and approval status across all active jurisdictions. • Develop and maintain current knowledge of submission and change management requirements for each licensed jurisdiction; update internal documentation as regulatory requirements evolve. • Support TC Operations activities including JIRA ticket review, compliance order management tracking, and quarterly project milestone management. • Serve as an operational point of contact for internal engineering, product, and QA teams on compliance requirements; interface with external regulators, independent testing labs, and vendors as required. • Identify and recommend opportunities for automation and process improvement within submission and change management workflows to support jurisdictional growth and operational efficiency. • Contribute to assurance monitoring activities during lower-volume submission cycle periods in collaboration with the broader Technical Compliance team. • Partner with Product and Technology teams during grooming and sprint planning to identify technical compliance requirements for new product development; ensure regulatory obligations are captured and incorporated prior to development commitment. • Review platform source code and collaborate directly with development and QA teams to evaluate bugs, code changes, and platform enhancements for regulatory impact; validate that software builds meet applicable jurisdictional technical standards prior to submission or deployment. • Assess and assign regulatory criticality classifications to development work items, determining the appropriate notification pathway and regulatory disclosure obligations for each change across applicable jurisdictions. • Provide timely compliance review of incidents and emergency change requests; evaluate regulatory exposure, document findings, and coordinate with engineering and compliance leadership to ensure any required regulator notifications or remediation actions are completed within required timeframes.