The Clinical Trials Operations Associate (CTOA) provides support to the clinical study teams in the execution of clinical trials. Primary responsibilities include maintaining Trial Master File (TMF) and assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. Contributes to the production and distribution of study materials and site/study communications.

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct:

  • Oversees CRO management of eTMF and CTMS or Establishes and maintains the internal TMF and CTMSWith minimal supervision of the CRA, CTM or Study Lead, the CTAO will review the CTMS/TMF for compliance, addressing findings as needed and supporting the study team with study activities
  • Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF
  • Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations
  • Manages incoming and outgoing clinical trial related materials shipments to site and temperature excursions, study team, CRAs and vendors, as needed
  • Assists with all aspects of initial study drug release including regulatory packet review and study-drug release
  • Assists clinical study team with the planning, preparation, and support of study related meetings including the generation of agendas and minutes as required.
  • Participates in the EDC, IXRS and other systems specification process and user acceptance testing, as appropriate
  • Communicates directly with sites, Site Management Organizations (SMOs), Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities
  • Ensures timely study entry and updates to Clinicaltrial. gov and maintains until end-of-study under supervision
  • Assists with tracking of clinical trial progress including creation and maintenance of study related trackers, status updates reports, as requested
  • Assists with review of project and study-related documents including: informed consent templates forms, TMF plans, synopses, protocols and amendments, and other study related documents, as required
  • Participates in clinical team meetings, including attending required meeting, and interacts in a positive, professional manner. May coordinate meetings/teleconference/WebEx. Prepares agendas, minutes and tracks action items.
  • Maintains unblinded IP inventory control in IXRS
  • Maintains completion of required corporate training on standards, policies, work instructions by due date
  • Performs other work-related duties as assigned

 

Qualifications:

  • Understanding in relevant clinical operations activities
  • Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision
  • Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required
  • Working knowledge of the DIA TMF Reference Model, TMF maintenance and management of essential documents via an eTMF
  • Solid interpersonal, written and verbal communication skills across study team including study management
  • Computer skills including proficiency in the use of Microsoft Outlook, Word, Excel, Powerpoint, and organization tools
  • Experience in Sharepoint or similar filing systems is desirable
  • Attention to detail and accuracy in work
  • Effective time management and organization skills
  • Ability to multi-task under limited direction and on own initiative

Education and Experience:

  • BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred but not required
  • 3-5 years experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting
  • Demonstrate basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan
  • Level and salary will be commensurate with experience

Please submit your resume to: careers@respivant.com