Onsite Clinical Study Specialist (3 days/wk)

Kps-Life; Cambridge (MA); Hybrid; USD 65,000 - 90,000; Full time

Job summary

KPS Life is seeking a Clinical Study Specialist to join our onsite team across Armonk, NY, Cambridge, MA, or Warren, NJ. This role supports study execution, site activation, enrollment tracking, TMF processes, and cross-functional coordination with sponsor partners.

The CSS collaborates with study leads and CROs to ensure timely, compliant trial activities, leveraging CTMS, EDC, IWRS/IVRS and MS Office tools.

Qualifications

• Bachelor’s degree or equivalent with 2+ years of relevant industry experience.
• Advanced degree in a related field with 1–2 years of relevant experience preferred.
• Strong attention to detail and ability to track information and deliver assigned study activities.
• Excellent communication and interpersonal skills with internal and external relationships.
• Strong organizational, prioritization, and time-management skills.
• Proactive and self-disciplined, with ability to meet deadlines and manage multiple priorities.
• Strong resourcefulness, problem-solving, and critical-thinking skills.
• Technical proficiency with CTMS, EDC, IWRS/IVRS and MS Office.

Responsibilities

• Organize and deliver reports, metrics, and study updates to the Clinical Study Lead.
• Schedule and coordinate study team meetings, agendas, and minutes.
• Support feasibility assessments and site selection activities.
• Review study documents including informed consent forms and CRFs per SOPs.
• Maintain study manuals and regulatory binders, with version control.
• Prepare training materials and investigator meeting materials.
• Track site activation, enrollment, and monitoring visits against plans.
• Escalate issues or delays related to site activation or monitoring plans.
• Monitor investigator and site status; support registry postings.
• Perform TMF reconciliations and track 1572 changes and disclosures.
• Manage SharePoint/sites and maintain accurate site contact information.
• Contribute to BD RMs and oversee TPVs as needed.

Skills

Attention to detail

Communication

Organizational skills

Time management

Proactive mindset

Problem solving

Study coordination

Education

Bachelor’s degree in related field

Advanced degree preferred

Tools

CTMS

EDC

IWRS/IVRS

MS Office/Teams

Job description

KPS Life is seeking a Clinical Study Specialist to join our onsite team across Armonk, NY, Cambridge, MA, or Warren, NJ. This role supports study execution, site activation, enrollment tracking, TMF processes, and cross-functional coordination with sponsor partners.

The CSS collaborates with study leads and CROs to ensure timely, compliant trial activities, leveraging CTMS, EDC, IWRS/IVRS and MS Office tools.