Senior Clinical Research Associate

What you’ll do Establish and maintain a document management system (eTMF) for regulatory paper and electronic files in a consistent, compliant format Maintain regulatory documentation in accordance with FDA regulations, ICH‑GCP guidelines, and company SOPs Ensure completeness, accuracy and timeliness of regulatory documents for study sites, sponsors and networks Maintain and update study‑related credentials for site staff and investigators Manage protocol amendments and informed consent form (ICF) updates in alignment with study protocols and IRB requirements Prepare, organize and submit IRB documentation for clinical trials Process and submit IND safety reports as delegated by the Principal Investigator, ensuring regulatory compliance Support internal and external audits and inspections by maintaining complete, accurate and accessible documentation Collaborate with clinical operations teams to identify and resolve regulatory issues Archive study documentation and correspondence in accordance with SOPs Participate in study, investigator and internal team meetings as required Support development of training materials and assist in creation and maintenance of clinical operations SOPs Monitor compliance trends and support investigation of non‑conformance issues Serve as a CTMS resource and support regulatory operations oversight Contribute to compliance monitoring across clinical trial operations What you’ll bring 2–6 years of clinical research experience, including at least 2 years in regulatory affairs or clinical trial documentation management Strong knowledge of FDA regulations and ICH‑GCP guidelines Knowledge of IRB processes and Good Clinical Practice (GCP) guidelines Experience with eTMF systems, CTMS, EDC systems and electronic medical records preferred Hands‑on experience managing eTMF and CTMS systems Experience in CRO, hospital or clinical site environments (e.g., CTA, CRA or clinical operations roles) with exposure to ICH‑GCP, regulatory documentation, IRB submissions and clinical trial monitoring Experience in decentralized clinical trials (DCTs) is a plus Background in regulatory or clinical affairs, including preparation of regulatory submissions Fluency in English Intense work ethic Collaborative spirit and problem‑solving approach How you’ll grow Cross‑functional skills development & custom learning pathways Milestone training programmes aligned to career progression opportunities Internal mobility paths that empower growth via s‑curves, individual contribution and role expansions Perks & Benefits At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well‑being, financial future, time away and professional development. With robust skills‑building programmes, multiple career progression paths, internal mobility and a deeply collaborative culture, you’ll have the opportunity to do meaningful work, expand your capabilities and thrive as part of a global community. Hybrid working model We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on‑site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face‑to‑face connections. Travel Travel is a requirement at ZS for client‑facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client‑facing ZSers should be prepared to travel as needed. Inclusion and belonging At ZS, we honor the visible and invisible elements of our identities, personal experiences and belief systems – the ones that comprise us as individuals, shape who we are and make us unique. We believe your personal interests, identities and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives and experiences. Equal Opportunity Employer ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. #J-18808-Ljbffr ZS