Clinical Trials Associate

Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical Operations team, providing operational and administrative support for the planning, startup, execution, and close-out of Attovia-sponsored clinical trials. This role reports to the Head of Clinical Operations or a Clinical Trial Manager (CTM). Working closely with Clinical Trial Managers (CTMs), Clinical Scientists, Quality Assurance, Regulatory Affairs, CROs, and other vendors, the CTA helps ensure studies are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and Attovia Standard Operating Procedures (SOPs). This role is ideal for an organized, detail-oriented individual who enjoys working in a fast-paced biotechnology environment and is interested in building a career in Clinical Operations. Key Responsibilities Clinical Trial Operations • Provide day-to-day operational support for one or more Phase 1–2 clinical studies. • Assist with study startup activities, including vendor onboarding, essential document collection, and tracking study milestones. • Support study maintenance activities throughout enrollment, treatment, and follow-up. • Assist with study close-out activities and Trial Master File (TMF) reconciliation. • Maintain study trackers, action item logs, and operational dashboards. Trial Master File (TMF) • Assist with the management and quality control of electronic Trial Master Files (eTMFs). • Review documents for completeness, accuracy, and TMF filing readiness. • Support TMF reconciliation with CROs and vendors. • Help prepare for TMF audits and inspections. Vendor and CRO Management • Coordinate meetings with CROs, vendors, and internal stakeholders. • Prepare meeting agendas, capture minutes, and track follow-up actions when needed. • Monitor completion of assigned action items. • Support vendor qualification and onboarding activities as requested. Documentation and Study Support • Assist with development and maintenance of study plans, contact lists, communication plans, and study documentation. • Coordinate document review and approval workflows. • Help to maintain study distribution lists and controlled documents. Regulatory and Compliance Support • Assist with collection and tracking of essential regulatory documentation. • Support inspection readiness activities. • Ensure documentation complies with ICH-GCP, company SOPs, and applicable regulations. • Assist with training documentation and study compliance tracking. Cross-Functional Collaboration • Work closely with Clinical Trial Managers to support multiple concurrent studies. • Collaborate with Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Clinical Supply, Biomarker Operations, and Quality Assurance functions. • Build productive working relationships with CROs, vendors, and investigator sites. Basic Qualifications • Bachelor's degree in Life Sciences, Nursing, Health Sciences, or related field. • 1–3 years of experience supporting clinical trials in biotechnology, pharmaceutical, CRO, or academic research environments. • Working knowledge of ICH-GCP guidelines and clinical research processes. • Excellent organizational and time management skills. • Strong written and verbal communication skills. • High attention to detail and ability to manage multiple priorities simultaneously. • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook). Preferred Qualifications • Experience supporting global Phase 1 or Phase 2 clinical trials. • Experience with eTMF systems (e.g., Veeva Vault TMF, Wingspan, or similar). • Familiarity with CTMS, eISF, EDC, or electronic quality management systems. • Experience working in a small biotechnology company. • Understanding of GCP inspections and audit readiness activities. • Exceptional organizational skills with strong attention to detail • Strong sense of accountability and follow-through on commitments • Ability to manage and prioritize multiple competing priorities in a fast-paced environment • Excellent written and verbal communication skills • Collaborative team player with a proactive approach to problem-solving • Adaptable and comfortable operating in a dynamic, evolving environment • Strong customer service orientation with internal and external stakeholders About Attovia Attovia™ is a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need. Our product candidates are internally discovered using our proprietary ATTOBODY™ platform, an evolution-driven, high-throughput biologics platform that enables the rapid discovery and creation of diverse biparatopic complex biologics. Our pipeline spans chronic pruritic diseases, inflammatory skin diseases, inflammatory bowel disease, and other immune-mediated conditions. Our values define how we make decisions, work with one another, and pursue our mission: • Integrity: We put patients first, uphold the highest ethical standards, and communicate with honesty and transparency • Learning & Growth: We ask questions, challenge the status quo, seek and provide constructive feedback, and invest in the development of ourselves and others • Drive for Excellence: We set ambitious goals, take ownership, honor our commitments, move with urgency, and deliver rigorous, high-quality, and data-driven work • Innovation: We pursue transformative science, think creatively, and do more with less through resourcefulness and continuous improvement • Teamwork & Collaboration: We communicate openly, debate constructively, mentor and learn from one another, and recognize that our strongest results come from working together We take pride in fostering a strong team and dynamic work environment, and we are seeking individuals who align with our values and contribute to a positive and impactful workplace.  Attovia is located in San Carlos, CA. Attovia is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, ancestry, national origin, religion or creed, age, sex, pregnancy, childbirth, breastfeeding or related medical conditions, sexual orientation, gender, gender identity or gender expression, marital status, medical condition, genetic information, physical or mental disability, military or veteran status, reproductive health decision-making, or any other characteristic protected by applicable federal, state, or local law. Learn more about Attovia: www.attovia.com Notice to Employment Agencies The Attovia talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the Human Resources department. Attovia shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.