Clinical Study Specialist — On-Site Trial Coordination

KPS Life; Cambridge (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

KPS Life in Cambridge, MA is seeking a Clinical Study Specialist to support clinical trial execution. This role collaborates with study leads, manages TMF-related tasks, and coordinates meetings, documents, and site activities.

The CSS will prepare reports, track enrollment, assist with site feasibility and regulatory documents, and ensure compliance with SOPs across studies for sponsor partners.

Qualifications

• Bachelor’s degree or equivalent with 2+ years of related experience preferred.
• Attention to detail and ability to track study activities.
• Strong communication and interpersonal skills; ability to build relationships.

Responsibilities

• Provides technical and administrative support to the clinical study team.
• Organizes reports and metrics for the clinical study lead.
• Schedules meetings, prepares agendas, minutes, and materials for study meetings.
• Manages documentation reviews (informed consent forms, case report forms) per SOPs.
• Tracks site activation, enrollment, monitoring visits, and deviations from plan.
• Maintains TMF with study lead guidance and supports regulatory postings.

Skills

Attention to detail

Communication skills

Problem solving

Time management

Team collaboration

Education

Bachelor’s degree

Advanced degree

Tools

CTMS

EDC

IWRS/IVRS

MS Office

Teams

Job description

KPS Life in Cambridge, MA is seeking a Clinical Study Specialist to support clinical trial execution. This role collaborates with study leads, manages TMF-related tasks, and coordinates meetings, documents, and site activities.

The CSS will prepare reports, track enrollment, assist with site feasibility and regulatory documents, and ensure compliance with SOPs across studies for sponsor partners.