Clinsmart Logo

Position: Part Time

Location: Newtown, PA (in-house)

In accordance with FDA regulations, ICH/GCP guidelines, study protocols, and the company SOPs, provides clinical research support and assistance with the start-up and management of clinical trial.

 

Duties and Responsibilities

  • Assists with conduct of site feasibility and associated tracking
  • Participates in the negotiation of site budgets and oversees the grant process
  • Coordinates the distribution and collection of site start up packets and essential documents
  • Scans and copies project documentation inclusive of, but not limited to, essential documents, study binders, CSRs, CRFs, and DCFs
  • 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
  • Maintains the Trial Master File / eTMF as required by the study plans
  • Files according to ClinSmart SOPs and/or Sponsor requirements along with ClinSmart quality standards and adhere to 98% accuracy across the major files sections and the documents contained therein
  • Forwards correspondence to sites, sponsors and project teams as needed
  • Archives study documentation and works with IT to return the TMF to sponsor, as directed
  • Procures, stores, and ships study supplies
  • Oversees investigational product and ancillary supply shipments and dispositions
  • Interfaces with vendors as required for a project
  • Participates in internal and external team meetings, provides updates as required, may take minutes or assist in maintaining the Minute Log
  • Provides support to the team communicating process improvement suggestions as applicable
  • General administrative duties
  • Resolves administrative issues on behalf of the Project Manager
  • Professionally represents ClinSmart in external meetings and regulatory inspections / audits
  • 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

 

Minimum Requirements

  • Associate degree preferred, ideally in the biological sciences or 1-2 years of experience in the CRO or pharmaceutical industry as project assistant or clinical trial assistant
  • Has an understanding of the clinical development process as it relates to Phase I-III Trials
  • Strong verbal and written communication skills
  • Computer literacy, proficiency in Microsoft Office, SharePoint and the ability to learn the appropriate software
  • Excellent interpersonal and organizational skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to manage multiple projects
  • Attention to detail
  • Good presentation skills