Clinical Trial Assistant
About The Position
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com. 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.
Requirements
- 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.
Nice To Haves
- Bachelor’s degree in life sciences, healthcare, biology, nursing, public health, or related discipline preferred.
- 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.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
