Clinical Project Coordinator

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Primary Purpose

The purpose of this role is to support Emmes clinical operations teams, providing logistics support for conference calls, supplies, documentation, and client/sponsor reporting needs as required by the statement of work.

Responsibilities
  • Provides support in tracking, compiling, and submitting project deadlines and deliverables.
  • Manages conference call accounts, schedule and distributes conference call information and materials (i.e., Agenda, Minutes, Supporting Documents).
  • Arranges the planning, organization, and coordination all aspects of conference calls and meetings, including international sites and collaborators.
  • Facilitates communications between project staff and project sponsors regarding project development and project processes.
  • Develops, consolidates, compiles, edits, formats, tracks and distributes technical reports (e.g., DSMB) or regulatory reports (e.g., IND, CSR, SAP), case report forms, manuals, presentations, manuscripts, adhering to eCTD and/or 508 compliance guidelines, as required.
  • Composes, consolidates, formats, edits, and distributes a wide variety of non- technical documents (e.g., numbered memos, site visit reports, project marketing materials).
  • Develops and maintains database software for entering, retrieving, modifying, and manipulating data to generate various documents such as rosters, meeting materials, and reports.
  • Establishes and maintains project procedures and processes (e.g., SOPs, work instructions).
  • Leads the managing of electronic and paper-based project files and archives.
  • Maintains the project website contents and user access.
  • Review quality, based on standards and SOPs and GCP guidelines, and contribute to department/TRU standardization efforts.
  • Responsible for tracking PubMed, NLM reporting, publications and manuscripts for the project; provides support in manuscript submission.


Experience

  • Requires Graduate/Post Graduate in Life Sciences .Incumbent typically will possess at least 2-4 years of relevant project or administrative support experience.
  • Strong familiarity and working knowledge of Microsoft Office applications, particularly MS Word.
  • Strong analytical skills.
  • Time management and decision-making skills
  • Attention to detail and the ability to address several assignments simultaneously
  • Must be able to organize and manage workload efficiently and prioritize projects with minimal supervision.
  • Must be able to work with minimal supervision to perform work that is varied and may be somewhat difficult in character.

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