What are the responsibilities and job description for the Clinical Study Specialist position at kps life?
Clinical Study Specialist (CSS)
📍 Hybrid (3 days/week in office) – Armonk, NY | Cambridge, MA | Warren, NJ | Uxbridge, UK | Dublin, Ireland
Shape the Future of Clinical Research
Are you passionate about advancing clinical trials and making a real impact on patient outcomes? We’re looking for a highly organized, detail-driven Clinical Study Specialist (CSS) to support the execution of innovative clinical programs across global teams.
In this role, you’ll be at the operational heart of clinical trials—collaborating with cross-functional teams, supporting study execution, and ensuring everything runs smoothly from start-up through close-out.
What You’ll Do
As a Clinical Study Specialist, You Will
What You Bring
Required
If you’re a proactive, detail-oriented professional who thrives in a collaborative clinical environment, we’d love to hear from you.
👉 Apply now and help bring life-changing therapies to patients worldwide.
#kpslife
📍 Hybrid (3 days/week in office) – Armonk, NY | Cambridge, MA | Warren, NJ | Uxbridge, UK | Dublin, Ireland
Shape the Future of Clinical Research
Are you passionate about advancing clinical trials and making a real impact on patient outcomes? We’re looking for a highly organized, detail-driven Clinical Study Specialist (CSS) to support the execution of innovative clinical programs across global teams.
In this role, you’ll be at the operational heart of clinical trials—collaborating with cross-functional teams, supporting study execution, and ensuring everything runs smoothly from start-up through close-out.
What You’ll Do
As a Clinical Study Specialist, You Will
- 📊 Deliver clear, actionable reports and metrics to support study oversight
- 📅 Coordinate and manage clinical study team meetings (agendas, materials, minutes)
- 🔍 Support feasibility assessments and site selection activities
- 📄 Assist in the review and management of key study documents (ICFs, CRFs, etc.)
- 📚 Maintain study manuals, reference binders, and version-controlled documentation
- 🎓 Prepare materials for investigator meetings and training sessions
- 🚀 Track site activation, enrollment, and monitoring progress—flagging risks early
- 🌐 Maintain investigator/site data and support clinical trial registry updates
- 🗂️ Reconcile and maintain Trial Master File (TMF) documentation
- 🤝 Coordinate with sites, vendors, and internal stakeholders
- 📈 Contribute to data review processes, including Blind Data Review Meetings
- 🔄 Track study close-out activities and ensure compliance
- 💡 Identify and recommend process improvements
What You Bring
Required
- Bachelor’s degree (or equivalent) with 2 years of relevant industry experience OR advanced degree with 1–2 years of experience
- Strong attention to detail and ability to manage multiple priorities
- Excellent communication and relationship-building skills
- Problem-solving mindset with a proactive approach
- Familiarity with clinical development processes and medical terminology
- Working knowledge of ICH/GCP guidelines
- Experience with clinical systems (CTMS, EDC, IWRS/IVRS)
- Proficiency in Microsoft tools (Teams, Office, Project, SharePoint)
- 🌍 Work on global, impactful clinical programs
- 🤝 Collaborate with experienced and supportive teams
- 📈 Grow your career in a fast-paced, innovative environment
- 🧠 Contribute ideas that shape processes and improve outcomes
If you’re a proactive, detail-oriented professional who thrives in a collaborative clinical environment, we’d love to hear from you.
👉 Apply now and help bring life-changing therapies to patients worldwide.
#kpslife