Clinical Trial Associate

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

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are seeking a Clinical Study Specialist to manage, implement and monitor clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.

Hybrid in: Warren NJ, Armonk NY or Cambridge MA 3x/week

What you will be doing

• Organizes and delivers analyzable reports and metrics to the clinical study lead
• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
• Collates data for assessments such as feasibility and site selection and reviews site usability database
• Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
• Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
• Collates materials for training and investigator meetings
• Tracks site activation, enrolment and monitoring visits to projected plans, and escalates any issues or delays with site activation or deviations from monitoring plan
• Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
• Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
• Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
• Manages and maintains team SharePoint and/or shared drive sites, as needed
• Communication with sites as directed and maintains site contact information
• Contributes to line listings review for Blind Data Review Meeting (BDRM)
• May manage or contribute to oversight of Third-Party Vendors (TPV)
• Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
• Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
• Proactively recommends process improvement initiatives for the department

Your profile

• Must have a bachelor's degree
• Must have a minimum of 2 years industry related work experience
• Experience supporting global trials (NA, LAM, EU, APAC, India)
• Experience working in TMF, CTMS, SharePoint,
• Excels in written and verbal communications
• Self-starter, can work independently with minimal oversight, solution-oriented
• ICF review experience
• Vendor management/oversight experience a plus
• Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programs including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resourcesLearning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.