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

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 (CSS) to be fully dedicated to our sponsor partner and work 3 days a week in one of their offices located in Armonk, NY, Warren, NJ, or Cambridge, MA. This role supports clinical trial teams with study coordination, documentation, tracking, and vendor support from study startup through closeout. We're looking for an organized, detail-oriented professional with strong communication skills and at least 2 years of clinical research experience.

Position Summary

The Clinical Study Specialist provides technical and administrative support to clinical study teams responsible for executing clinical trials. This role supports one or more studies across a clinical development program, working closely with study leadership, cross-functional partners, clinical research organizations (CROs), and external vendors. Responsibilities may include supporting both internally managed and outsourced studies.

Key Responsibilities

• Prepare and organize study reports, metrics, and tracking tools to support study oversight and decision-making.
• Coordinate study meetings, including scheduling, preparing agendas and presentation materials, documenting minutes, and tracking action items.
• Compile data to support study feasibility assessments and site selection.
• Assist with reviewing study documents, including informed consent forms and case report forms, and coordinate document reviews in accordance with standard operating procedures.
• Compile and maintain study manuals, reference materials, and regulatory, pharmacy, and laboratory binders, ensuring appropriate version control.
• Coordinate materials for study training sessions and investigator meetings.
• Track site activation, enrollment, and monitoring visits against study plans; elevate delays, issues, or deviations to study leadership.
• Maintain investigator and site information and support clinical trial registry postings and updates.
• Perform scheduled Trial Master File (TMF) reconciliations under the guidance of study leadership.
• Track and support the collection of required study documentation, including Form FDA 1572 updates and financial disclosure forms.
• Maintain study team collaboration sites, shared drives, and document repositories.
• Communicate with study sites as directed and maintain accurate site contact information.
• Support the review of data listings for blinded data review meetings.
• Assist with third-party vendor coordination and oversight, as assigned.
• Track study closeout activities, including required documentation, investigational product reconciliation, and clinical research associate closeout visits.
• Identify and recommend opportunities to improve study processes and departmental efficiency.

Qualifications

• Bachelor's degree or equivalent, with at least two years of relevant industry experience preferred; alternatively, an advanced degree in a related field with one to two years of relevant experience preferred.
• Strong attention to detail and organizational skills, with the ability to track information accurately and complete assigned study activities.
• Effective communication and interpersonal skills, with the ability to build productive relationships with internal and external partners.
• Resourcefulness, sound problem-solving skills, and the ability to assess information and recognize potential impacts on clinical trials.
• Proficiency with Microsoft Office and collaboration tools, such as Teams and SharePoint, and familiarity with clinical trial systems, including CTMS, EDC, and IRT/IWRS/IVRS.
• Ability to work proactively, prioritize competing responsibilities, and meet deadlines.
• Basic knowledge of medical terminology and the clinical drug development process.
• Familiarity with International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

Travel

Travel of up to 25% may be required.