Clinical Study Specialist

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

Clinical Study Specialist - (Armonk, NY, Cambridge MA or Warren, NJ)

Warren, NJ, Armonk, NY or Cambridge, MA

Opportunity Details

On Assignment Clinical Study Specialist - (Armonk, NY, Cambridge MA or Warren, NJ)

KPS Life is hiring Clinical Study Specialists to be fully dedicated and onsite 3 days per week at our sponsor partner located in Warren, NJ, Armonk, NY or Cambridge, MA.

We’re seeking clinical research professionals with 2+ years of industry experience who are highly organized, detail-oriented, proactive, and passionate about clinical trial execution. In this role, you’ll support clinical study teams across trial activities including site activation and enrollment tracking, study documentation, TMF reconciliation, investigator/site communications, meeting coordination, metrics and reporting, and study close-out activities.

If you have experience with clinical trial systems such as CTMS, EDC, IWRS/IVRS and strong MS Office/Teams skills, this could be a great opportunity to grow your career while making an impact in clinical development.

Clinical Study Specialist (CSS)

Position Overview

The Clinical Study Specialist (CSS) provides technical and administrative support to clinical study teams responsible for clinical trial execution. The CSS may support one or more studies within a program and receives assignments from the Clinical Study Lead or Clinical Study Associate Manager.

The CSS may support both internally sourced studies and studies outsourced to Clinical Research Organizations (CROs).

Key Responsibilities

• Organize and deliver reports, metrics, and study updates to the Clinical Study Lead.
• Schedule and coordinate clinical study team and study-related meetings, including agendas, presentations, minutes, and follow-up activities.
• Support feasibility assessments and site selection activities, including data collection and review of site usability databases.
• Contribute to the review of study documents, including informed consent forms and case report forms, in accordance with company SOPs.
• Compile and maintain study manuals, reference binders, and study materials, including regulatory, pharmacy, and laboratory binders.
• Maintain version control of study reference materials.
• Prepare and coordinate materials for training sessions and investigator meetings.
• Track site activation, enrollment, and monitoring visits against projected plans.
• Escalate issues or delays related to site activation or deviations from monitoring plans.
• Monitor and update investigator and site status throughout the trial.
• Support clinical trial registry postings.
• Perform scheduled Trial Master File (TMF) reconciliations with guidance from the Clinical Study Lead.
• Support the receipt and tracking of scheduled reports, including Form 1572 reportable changes and financial disclosure forms.
• Manage and maintain team SharePoint sites and/or shared drives as needed.
• Communicate with clinical sites as directed and maintain accurate site contact information.
• Contribute to line listing reviews for Blind Data Review Meetings (BDRMs).
• May manage or contribute to the oversight of Third-Party Vendors (TPVs).
• Track and monitor study close-out activities, including Form 1572s, Investigational Product reconciliation, Financial Disclosures, and CRA close-out visits.
• Proactively identify and recommend process improvement opportunities.

Qualifications & Requirements

• Bachelor’s degree or equivalent with a minimum of 2+ years of relevant industry experience, or an advanced degree in a related field with 1–2 years of relevant experience preferred.
• Strong attention to detail and ability to accurately track information and deliver assigned study activities.
• Excellent communication and interpersonal skills with the ability to build effective internal and external relationships.
• Strong organizational, prioritization, and time-management skills.
• Proactive and self-disciplined, with the ability to meet deadlines and manage multiple priorities.
• Strong resourcefulness, problem-solving, and critical-thinking skills.
• Ability to proactively assess information and investigate potential impacts on clinical trials.
• Technical proficiency with clinical trial systems and Microsoft applications, including Teams, MS Office, Project, CTMS, EDC, and IWRS/IVRS.
• Basic familiarity with medical terminology and clinical drug development.
• Awareness of ICH/GCP principles.

Travel

• May require up to 25% travel.

Work Location

This position is fully dedicated and requires onsite work 3 days per week at a sponsor partner location in one of the following: