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Position: Full Time

Location: Newtown, PA (in-house)

The Clinical Project Assistant is responsible for providing operational support for studies conducted by the ClinSmart Clinical Operations team, and work in partnership with internal colleagues, external partners, and clients to ensure delivery to time, quality, and cost expectations.


Duties and Responsibilities

  • Coordinates the distribution and collection of site start up packets and essential documents

  • Reviews deliverable to ensure accuracy of content and materials copied

  • Reports all document collection and tracking issues to the Project Team on a regular basis

  • Establishes the Trial Master File / eTMF in accordance with SOPs, project, organizational and regulatory requirements

  • Creates, updated, tracks, and maintains the Trial Master File / eTMF as required by the study plans

  • Archives study documentation and works with IT to return the TMF to sponsor, as directed

  • Procures, stores, and ships study supplies

  • Manages site payments, including reviewing, tracking, and reconciliation between the bank, in-house accounting, and the client

  • Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently

  • Assists with final site TMF review and Close Out Visit reconciliation packets. Communicate findings and provide packs to CRAs

  • Keep minutes for internal and external project meetings

  • General administrative duties

Knowledge and Skills

  • Knowledge of applicable regulatory guidelines (i.e. ICH and GCP)

  • Possess a general understanding of clinical trial issues, strong attention to detail, and meticulous follow-through

  • Proficiency using Microsoft Outlook, Word, PowerPoint, and Excel

  • Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures in a fast-paced environment

  • Exceptional oral, written, and interpersonal skills

Minimum Requirements

  • BS/BA in a relevant scientific discipline is preferred

  • Minimum 3 years related experience, preferably in the pharmaceutical industry or equivalent