Clinical Study Specialist - Hybrid (3x/wk)

ICON Strategic Solutions; Cambridge (MA); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programs

Retirement plans

Career development

Job summary

ICON Strategic Solutions is seeking a Clinical Study Specialist to manage and monitor clinical studies in a sponsor-dedicated model. The role supports TMF, CTMS, and SharePoint processes in a hybrid setup across Warren NJ, Armonk NY, or Cambridge MA.

You will coordinate meetings, prepare materials, review study documents, and track site activation and enrollment while ensuring compliance with SOPs and regulations. A bachelor's degree and 2+ years of experience are required.

Qualifications

• Bachelor's degree required
• Minimum 2 years industry-related work experience
• Experience supporting global trials (NA, LAM, EU, APAC, India)
• Experience working in TMF, CTMS, SharePoint
• Excellent written and verbal communications
• Self-starter who can work independently with minimal oversight
• ICF review experience is a plus
• Vendor management/oversight experience is a plus

Responsibilities

• Organizes and delivers analyzable reports and metrics to the clinical study lead
• Schedules and coordinates meetings, prepares agendas and minutes for clinical study team meetings
• Coupons data for feasibility and site selection and reviews site usability database
• Reviews study documents such as informed consent forms and case report forms
• Maintains study manuals and versioning of study reference materials
• Tracks site activation, enrollment and monitoring visits and escalates issues
• Manages TMF reconciliation and ensures regulatory reporting requirements
• Oversees SharePoint and/or shared drive sites and maintains site contacts

Skills

Written and verbal communication

Self-starter

Problem solving

Vendor management

Education

Bachelor's degree

Tools

TMF

CTMS

SharePoint

Job description

ICON Strategic Solutions is seeking a Clinical Study Specialist to manage and monitor clinical studies in a sponsor-dedicated model. The role supports TMF, CTMS, and SharePoint processes in a hybrid setup across Warren NJ, Armonk NY, or Cambridge MA.

You will coordinate meetings, prepare materials, review study documents, and track site activation and enrollment while ensuring compliance with SOPs and regulations. A bachelor's degree and 2+ years of experience are required.