Clinical Study Specialist

KPS Life is looking to hire a Clinical Study Specialist to be fully dedicated to one of our sponsor partners. This hybrid role requires 3 days per week in the office in either Warren, NJ, Cambridge, MA or Armonk, NY. Clinical trial experience at a pharmaceutical company or CRO is required. We’re seeking a detail‑oriented professional to provide critical operational and administrative support to clinical study teams. If you have strong organizational skills and experience supporting clinical trials, we’d love to hear from you. Clinical Study Specialist (CSS) Role Overview The Clinical Study Specialist provides technical and administrative support to clinical study teams responsible for trial execution. The CSS may support one or more studies within a program and will work closely with the Clinical Study Lead or Clinical Study Associate Manager. This role supports both internally managed studies and studies outsourced to Clinical Research Organizations (CROs). Key Responsibilities Organize and deliver reports, metrics, and study tracking information to the Clinical Study Lead Schedule and coordinate meetings, prepare agendas, presentation materials, and distribute meeting minutes Support feasibility assessments, site selection activities, and review of site usability data Assist with the review and coordination of key study documents, including informed consent forms and case report forms Compile and maintain study reference materials, including regulatory, pharmacy, and laboratory binders, ensuring proper versioning Coordinate training materials and support the planning of investigator meetings Track site activation, enrollment, and monitoring visit progress against projected timelines; escalates issues or deviations as needed Maintain accurate investigator and site status information and support clinical trial registry postings Perform scheduled Trial Master File (TMF) reconciliations under the guidance of the Clinical Study Lead Support the collection and tracking of required regulatory documents (e.g., 1572 updates, financial disclosure forms) Manage and maintain team SharePoint sites and shared drives Serve as a point of contact for sites as directed and maintain up-to-date site contact information Contribute to line listings review in preparation for Blind Data Review Meetings (BDRM) Provide oversight support for third‑party vendors when required Track and support study close‑out activities, including collection of required documents and coordination of CRA close‑out visits Identify and recommend process improvement opportunities Qualifications Bachelor’s degree (or equivalent) with a minimum of 2+ years of relevant industry experience, or an advanced degree with 1–2 years of relevant experience Clinical trial experience at a pharmaceutical company or CRO is required Strong attention to detail with the ability to manage multiple tasks and deliver on assigned activities Excellent written and verbal communication skills with the ability to build effective working relationships Demonstrated problem‑solving skills and resourcefulness Ability to proactively assess information and understand its impact on clinical trials Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, Project) and clinical systems such as CTMS, EDC, and IWRS/IVRS Self‑motivated with strong organizational skills and the ability to meet deadlines Basic understanding of medical terminology and clinical drug development Working knowledge of ICH/GCP guidelines Travel: Up to 25% may be required. #J-18808-Ljbffr kps life