Hybrid Clinical Study Specialist — 3 Days On-Site

KPS Life; Cambridge (MA); Hybride; USD 65 000 - 90 000; Temps partiel

Résumé du poste

KPS Life is hiring a Clinical Study Specialist to support sponsor partner trials through coordination, documentation, and vendor oversight. The role offers three in-office days per week at Cambridge, MA, with travel up to 25%.

The ideal candidate has 2+ years of clinical research experience and strong organizational and communication skills. The CSS will assist with TMF reconciliations, regulatory binders, study manuals, and data listings while collaborating with CROs, vendors, and study

Qualifications

• Bachelor's degree (or equivalent) with 2+ years in clinical research preferred; advanced degree with 1–2 years preferred.
• Strong attention to detail and organization to track information and complete activities.
• Effective communication and interpersonal skills for internal and external partners.
• Resourceful with problem-solving and understanding implications for trials.
• Proficiency with Microsoft Office and collaboration tools (Teams/SharePoint); familiarity with CTMS, EDC, IRT/IWRS/IVRS.
• Ability to prioritize, meet deadlines, and work proactively.
• Basic knowledge of medical terminology and clinical drug development processes.
• Familiarity with ICH-GCP guidelines.

Responsabilités

• Prepare and organize study reports, metrics, and tracking tools for oversight.
• Coordinate study meetings, agendas, minutes, and action items.
• Compile data for feasibility and site selection analyses.
• Review study documents such as informed consent forms and case report forms.
• Maintain study manuals, binders, and regulatory materials with version control.
• Coordinate materials for training sessions and investigator meetings.
• Track site activation, enrollment, and monitoring visits; escalate delays.
• Maintain site information and support trial registry postings.
• Perform TMF reconciliations under guidance from study leadership.
• Track and collect required study documentation (FDA forms, disclosures).
• Maintain collaboration sites, shared drives, and document repositories.
• Communicate with study sites and maintain accurate contact info.
• Support data listings reviews for blinded data reviews.
• Assist with vendor coordination and oversight as needed.
• Track closeout activities and investigational product reconciliation.
• Identify opportunities to improve study processes and departmental efficiency.

Connaissances

Attention to detail

Organizational skills

Communication skills

Team collaboration

Proactive work

Problem solving

Time management

Formation

Bachelor's degree in life sciences or related

Advanced degree (optional)

Outils

CTMS

EDC

IRT/IWRS/IVRS

Microsoft Office

Teams

SharePoint

Description du poste

KPS Life is hiring a Clinical Study Specialist to support sponsor partner trials through coordination, documentation, and vendor oversight. The role offers three in-office days per week at Cambridge, MA, with travel up to 25%.

The ideal candidate has 2+ years of clinical research experience and strong organizational and communication skills. The CSS will assist with TMF reconciliations, regulatory binders, study manuals, and data listings while collaborating with CROs, vendors, and study