Clinical Study Specialist

<h3>Armonk, NY, Cambridge , MA or Warren, NJ </h3><h3>Opportunity Details </h3><p>On Assignment <b>Clinical Study Specialist </b> </p><p>Armonk, NY, Cambridge , MA or Warren, NJ </p><p>KPS Life is looking to hire a Clinical Study Specialist to be fully dedicated to one of our sponsor partners. This is a hybrid role requiring 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. </p><p>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. </p><h3>Clinical Study Specialist (CSS) </h3><h3>Role Overview </h3><p>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). </p><h3>Key Responsibilities </h3><ul><li>Organize and deliver reports, metrics, and study tracking information to the Clinical Study Lead </li><li>Schedule and coordinate meetings, prepare agendas, presentation materials, and distribute meeting minutes </li><li>Support feasibility assessments, site selection activities, and review of site usability data </li><li>Assist with the review and coordination of key study documents, including informed consent forms and case report forms </li><li>Compile and maintain study reference materials, including regulatory, pharmacy, and laboratory binders, ensuring proper versioning </li><li>Coordinate training materials and support the planning of investigator meetings </li><li>Track site activation, enrollment, and monitoring visit progress against projected timelines; escalate issues or deviations as needed </li><li>Maintain accurate investigator and site status information and support clinical trial registry postings </li><li>Perform scheduled Trial Master File (TMF) reconciliations under the guidance of the Clinical Study Lead </li><li>Support the collection and tracking of required regulatory documents (e.g., 1572 updates, financial disclosure forms) </li><li>Manage and maintain team SharePoint sites and shared drives </li><li>Serve as a point of contact for sites as directed and maintain up-to-date site contact information </li><li>Contribute to line listings review in preparation for Blind Data Review Meetings (BDRM) </li><li>Provide oversight support for third-party vendors when required </li><li>Track and support study close-out activities, including collection of required documents and coordination of CRA close-out visits </li><li>Identify and recommend process improvement opportunities<br /></li> </ul><h3>Qualifications </h3><ul><li>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 </li><li>Clinical trial experience at a pharmaceutical company or CRO is required </li><li>Strong attention to detail with the ability to manage multiple tasks and deliver on assigned activities </li><li>Excellent written and verbal communication skills with the ability to build effective working relationships </li><li>Demonstrated problem-solving skills and resourcefulness </li><li>Ability to proactively assess information and understand its impact on clinical trials </li><li>Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, Project) and clinical systems such as CTMS, EDC, and IWRS/IVRS </li><li>Self-motivated with strong organizational skills and the ability to meet deadlines </li><li>Basic understanding of medical terminology and clinical drug development </li> </ul> #J-18808-Ljbffr