Website ZS
ZS
Company : ZS
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ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
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What you’ll do: Senior Research Associate in the Medical & Scientific Expertise Center will…
The Senior Clinical Research Associate supports the ongoing maintenance, organization, and compliance of clinical trial documentation across industry-sponsored studies and/or clinical sites. This role ensures accurate and timely documentation management to support regulatory compliance, inspection readiness, and overall clinical trial integrity. The position works closely with clinical operations, quality, and regulatory teams to support documentation management, compliance activities, and the broader clinical trial program.
This role collaborates across functional teams to support the company’s Compliance Program, including assisting with the implementation and maintenance of written policies, procedures, and standards of conduct, supporting training initiatives, and contributing to clinical study monitoring, auditing, and corrective action processes.
This is a hands-on clinical operations role within a CRO environment, focused on execution, documentation, and operational support across multiple clinical trial engagements.
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 SOP
- 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 Operation 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; must demonstrate strong knowledge of FDA regulations and ICH-GCP guidelines.
- Strong knowledge of clinical research terminology and clinical trial operations end-to-end clinical trial operations
- Knowledge of IRB processes, FDA regulations, and Good Clinical Practice (GCP) guidelines
- Experience with eTMF systems, CTMS, EDC systems, and electronic medical records preferred
- Demonstrated hands-on experience managing eTMF and CTMS system
- Strong working knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes
- Experience in CRO, hospital, or clinical site environments (e.g., CTA, CRA, or clinical operations roles), with hands-on exposure to ICH-GCP, regulatory documentation, IRB submissions, and clinical trial monitoring.
- Experience in decentralized clinical trials (DCTs) a plus
- Background in regulatory or clinical affairs, including preparation of regulatory submissions, preferred.
- Fluency in English
- Intense work ethic
- Collaborative spirit and problem-solving approach
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How you’ll grow:
- Cross-functional skills development & custom learning pathways
- Milestone training programs 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 programs, 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. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
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. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
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. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you’re eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
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.
To complete your application:
Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
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