Sr. Clinical Trial Assistant

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

The  Senior Clinical Trial Assistant (Sr. CTA) provides support to cross-functional teams in the planning, start-up, maintenance and closeout of study activities conducted within the Clinical Operations Department, in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulations and in accordance with Zogenix Standard Operating Procedures. 

Responsibilities 

  • Assists with in-house reconciliation of IWRS queries to ensure compliance with case report forms (EDC), protocol, pharmacy manual and Standard Operating Procedures (SOPs). 
  • Assists in identifying sites for oversight visits based on pre-specified criteria (i.e., repeat major deviations, failure to perform drug accountability appropriately, etc. 
  • Manages the collection, review, and approval of regulatory and essential documents from clinical sites 
  • Assists with the submission of protocols, amendments, subject facing documents to Independent Ethics Committees/Institutional Review Boards (IRBs) and coordinates responses to queries, as required 
  • Conduct study monitoring visits and co-monitoring visits as needed
  • Assists in the development of and facilitation of training for investigators and sites
  • Manages the TMF and assists in TMF QC- related activities 
  • Interfaces with site coordinators, field clinical staff, CROs and other company representatives 
  • Assists in the performance of study feasibility assessments 
  • Coordinates investigational product release activities across clinical sites 
  • Orders and assembles study files for Zogenix conducted studies 
  • Oversees ordering and shipping of specified supplies for clinical studies and maintains inventories 
  • Coordinates the preparation of Investigator and Study Coordinator Meetings 
  • Maintains tracking systems and reports study metrics to support the clinical trial 
  • Trains other Clinical Research Assistants, as required 
  • Assigns study site numbers 
  • Participates in and presents status updates in project team meetings 
  • Assists in User Acceptance Testing for various clinical systems 
  • Assists in study invoices/budget tracking/oversight as required 
  • Assists in the facilitation of team meetings (including development of agendas and minutes taking) 
  • Recommends and implements innovative process ideas to impact clinical trials management
  • Other duties as assigned.

PROFESSIONAL QUALITIES

  • Strong attention to detail
  • Highly accountable
  • Self-starter
  • Highly adept communicator; ability to assimilate and disperse information suitable for various audiences
  • Team player who enjoys interaction with different functions

CORE COMPETANCIES

  • Manages ambiguity
  • Collaboration
  • Action oriented
  • Plans and aligns

QUALIFICATIONS

  • Bachelor’s degree in a health sciences field preferred 
  • 3+ years’ experience in a similar role in the life science industry 
  • Sound understanding of GCP and other applicable guidelines/regulations 
  • Proficient in software applications such as Word, Excel and PowerPoint 
  • Good written and verbal communication skills 
  • Able to work independently while exercising initiative, flexibility and sound judgment.
  • Able to set priorities and juggle multiple demands.
  • Strong organizational skills with attention to detail 
  • Good problem-solving and analytical skills 
  • Experienced in working with and managing TMFs
  • Experience in being responsible for the processing of TMF documents is highly desirable
  • Experience in working with common Clinical Operations systems (EDC, IWRS, vendor portals, etc.)
  • Lead and/or participated in process improvement/efficiency initiatives

Other Skills

  • Excellent written and verbal communication skills
  • Possess excellent interpersonal skills
  • Proficiency with MS Word, Excel, Outlook, Project and PowerPoint
  • Demonstrated creativity and innovation to support projects and initiatives
  • Attention to detail

Special Working Conditions

  • Ability to travel as required

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