Onsite Clinical Study Specialist | CTMS/EDC Pro, 25% Travel

kps life; Warren (MA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Onsite work 3 days/week

Job summary

KPS Life is seeking a Clinical Study Specialist to support clinical trial execution onsite 3 days per week at sponsor partner locations in Warren, NJ, Armonk, NY, or Cambridge, MA. The CSS will assist with site activation, enrollment tracking, TMF reconciliations, and study communications, among other duties.

The role requires 2+ years in clinical research, strong organizational and communication skills, and proficiency with CTMS/EDC/IWRS and MS Office. Travel up to 25% may be involved.

Qualifications

• Bachelor's degree or equivalent with 2+ years of relevant industry experience (or advanced degree with 1–2 years preferred).
• Strong attention to detail and ability to track information and deliver study activities.
• Excellent communication and interpersonal skills with ability to build relationships.
• Strong organizational, prioritization, and time-management skills.
• Proactive and self-disciplined with ability to meet deadlines and manage multiple priorities.
• Technical proficiency with clinical trial systems and Microsoft applications (Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS).
• Familiarity with medical terminology and clinical drug development; awareness of ICH/GCP principles.

Responsibilities

• Organize and deliver reports, metrics, and study updates to the Clinical Study Lead.
• Schedule and coordinate study team meetings, including agendas, presentations, minutes, and follow-ups.
• Support feasibility assessments and site selection activities, including data collection and site usability review.
• Assist in review of study documents (informed consent, case report forms) per SOPs.
• Maintain study manuals, reference binders, and materials (regulatory, pharmacy, laboratory).
• Maintain version control of study reference materials.
• Prepare materials for training sessions and investigator meetings.
• Track site activation, enrollment, and monitoring visits against plans.
• Escalate issues related to site activation or monitoring deviations.
• Monitor investigator and site status; support registry postings.
• Perform TMF reconciliations with guidance from Clinical Study Lead.
• Track Form 1572 reportable changes and financial disclosures.
• Manage SharePoint sites and shared drives.
• Communicate with clinical sites and maintain site contact information.
• Contribute to line listing reviews for BDREAMs; oversee TPVs as needed.
• Track close-out activities and product reconciliation; advise on improvements.

Skills

Clinical study coordination

Documentation

Communication

Project management

MS Office/Teams

Education

Bachelor's degree or equivalent in related field

Advanced degree in related field

Tools

CTMS

EDC

IWRS/IVRS

Job description

KPS Life is seeking a Clinical Study Specialist to support clinical trial execution onsite 3 days per week at sponsor partner locations in Warren, NJ, Armonk, NY, or Cambridge, MA. The CSS will assist with site activation, enrollment tracking, TMF reconciliations, and study communications, among other duties.

The role requires 2+ years in clinical research, strong organizational and communication skills, and proficiency with CTMS/EDC/IWRS and MS Office. Travel up to 25% may be involved.