Clinical Study Specialist

kps life

Hackensack, NJPart-timePosted Mar 31, 2026

80K–100K a year

Behavioral Health Market Context

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Job Description

 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
• 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

Note:

Up to 25% travel may be required.
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
Technical Skills
• Experience with clinical systems (CTMS, EDC, IWRS/IVRS)
• Proficiency in Microsoft tools (Teams, Office, Project, SharePoint)
Why Join Us?
• 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
Ready to Make an Impact?

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.
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Qualifications

  • Up to 25% travel may be 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)
  • Contribute ideas that shape processes and improve outcomes

Benefits

  • Work on global, impactful clinical programs
  • Collaborate with experienced and supportive teams
  • Grow your career in a fast-paced, innovative environment

Responsibilities

  • 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
  • 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


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