Clinical Study Coordinator – Trials & TMF Support

KPS Life; Cambridge (MA); Híbrido; USD 65 000 - 90 000; Tempo integral

Resumo da oferta

KPS Life is hiring a Clinical Study Specialist to support sponsor-led trials, coordinating documentation, tracking, and vendor support from study startup through closeout. The role emphasizes organization, attention to detail, and strong communication.

You will work three days per week in Armonk, NY, Warren, NJ, or Cambridge, MA, collaborating with study leadership, CROs, and external vendors. A minimum of two years in clinical research is preferred, with proficiency in CTMS, EDC, and related

Qualificações

• Bachelor’s degree or equivalent; advanced degree preferred.
• Strong attention to detail and organization to track information and complete activities.
• Excellent communication and interpersonal skills with internal and external partners.
• Resourcefulness and problem-solving abilities.
• Proficiency with Microsoft Office and collaboration tools (Teams/SharePoint); familiarity with CTMS, EDC, IRT/IWRS/IVRS.

Responsabilidades

• Prepare and organize study reports, metrics, and tracking tools.
• Coordinate study meetings, agendas, minutes, and action items.
• Assist with data for feasibility assessments and site selection.
• Review study documents and ensure SOP alignment.
• Maintain study manuals and regulatory binders with version control.
• Coordinate training materials and investigator meetings.
• Track site activation, enrollment, and monitoring visits; escalate delays.

Conhecimentos

Attention to detail

Organizational skills

Communication skills

Problem-solving

Deadline oriented

Medical terminology

ICH-GCP familiarity

Formação académica

Bachelor's degree or equivalent

Advanced degree in related field

Ferramentas

Microsoft Office

Teams

SharePoint

CTMS

EDC

IWRS/IVRS

Descrição da oferta de emprego

KPS Life is hiring a Clinical Study Specialist to support sponsor-led trials, coordinating documentation, tracking, and vendor support from study startup through closeout. The role emphasizes organization, attention to detail, and strong communication.

You will work three days per week in Armonk, NY, Warren, NJ, or Cambridge, MA, collaborating with study leadership, CROs, and external vendors. A minimum of two years in clinical research is preferred, with proficiency in CTMS, EDC, and related