The Position

The Clinical Trial Specialist (CTS) will assist with clinical study execution activities as part of the Verve Clinical Trial Team (CTT). The CTS will support the Clinical Operations project team(s) with clinical trial management activities as assigned. The ideal candidate will be detail oriented, possess strong communication skills, be a quick learner, and feel comfortable functioning autonomously in a fast-paced environment.

Job Responsibilities

• Organize/maintain study tracking tools to support the conduct and oversight of assigned clinical studies
• Contribute to development of key study documents, plans, and templates (i.e., informed consent forms, study conduct and oversight plans, patient facing materials, vendor manuals and templates, study binders, etc.)
• Coordinates internal study related meetings including meeting scheduling/logistics, preparation and distribution of meeting agendas and minutes, and filing of relevant materials in the study Trial Master File (TMF)
• Responsible for filing required departmental documentation in the study TMF and assisting other functional areas with filing, if necessary
• Performs routine quality reviews of the TMF in line study needs
• Manages one or more study vendors including vendor selection/qualification, vendor startup, vendor maintenance/conduct, vendor closeout. Provides regular vendor updates to the Director of Clinical Operations and other Clinical Operations personnel as needed and escalates any issues/trends in a timely manner
• Assists with registering applicable clinical trials on public registries (i.e., clinicaltrials.gov) and submission of clinical study results as required by applicable local regulations
• Supports Sponsor oversight of clinical study centers and assigned CRA resources through continuing site monitoring report review and on-site Sponsor Oversight visits
• As delegated, leads certain study-specific processes according to SOPs and/or study-specific plans (i.e., protocol deviation review process)
• Communicates study updates to the CTT including any identified routine and specific communications with one or more functional areas as necessary (i.e., notification to Verve Regulatory of new and/or updated 1572s, etc.)
• Reviews vendor invoices against executed Scopes of Work
• Supports site and vendor contract negotiations
• Assists in ongoing data reviews and reconciliations as necessary
• Participates in development of departmental processes, SOPs, and initiatives
• Other duties as assigned

Qualifications

• Bachelor’s degree in a scientific or healthcare discipline preferred
• Minimum 3+ years of experience in clinical trial operations at Sponsor company
• Fundamental knowledge of GCP/ICH and applicable regulations
• Experience in relevant therapeutic area and/or technology platform preferred, but not required
• Experience in multiple phases of clinical studies preferred
• Excellent interpersonal and communications skills (verbal and written), as well as problem solving and organization skills
• Proven ability to work independently
• Self-motivated, pro-active, and resourceful with the ability to work in a fast-paced environment
• High level of proficiency in MS Office (i.e., Word, Excel, PowerPoint) strongly preferred
• Experience with relevant clinical trial systems (i.e., IRT, EDC, CTMS, eTMF, etc.) preferred

This is a hybrid role and requires 3 days minimum working in our Boston office.