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Clinical Trial Specialist

Company: George Clinical
Location: Memphis
Posted on: January 16, 2022

Job Description:

An opportunity has arisen for an experienced and adaptable Clinical Trial Specialist to join our Clinical Operations team- office based in Memphis, TN or Kansas City, MO
About us: - A growing, global Clinical Research Organization - A unique point of difference - our profits support The George Institute - a not-for-profit medical research institution - Flexible working conditions
Role PurposeThe Clinical Trial Specialist (CTS) is a member of the clinical project team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB requirements, and applicable SOPs and guidelines.
Key Accountabilities

  • Coordinates feasibility process for proposed and assigned trials
  • Provides ongoing site management to ensure project completion within designated timelines
  • Establish and maintain the Trial Master File (TMF)
  • IRB Submissions
  • Essential Documents - Site Startup
  • Collect Essential Documents from site during site startup
  • Compile / prepare/submit Essential Document Package (EDP) for regulatory readiness
  • Ensure quality product deliverables at all times
  • Setup and manage Study Portal, as needed/if applicable
  • Setup and manage trackers as assigned by PM/CTM
  • Maintains a professional approach respecting the dignity and confidentiality of associates, manager, and vendors
    Skills, Knowledge and Experience
    • Bachelors degree preferred; healthcare related preferred and three years of healthcare research experience required; OR 4+ years work related experience and/or training.
    • Two years of work experience in clinical research experience preferred
    • Must have exceptional communication skills in both verbal and written form
    • Must be skilled in working independently as well as working as part of a team
    • Must be proficient with the following software: Word, Excel, Power Point and Adobe Acrobat
    • Must be able to prioritize multiple projects and coordinate these efforts
    • Must be able to maintain confidentiality of information and procedures developed
    • Must be able to promote a positive customer service image and maintain positive working relationships with internal and external customers
    • Must have an understanding of GCP/ICH guidelines and FDA regulatory requirements
      We are searching for individuals who are results oriented and able to handle rapidly changing priorities in a fast moving environment. You must be willing to extend yourself, take on new challenges with a 'can do' attitude and work with regionally based team members. To apply, please send your CV to Follow us on LinkedIn to learn more about your future with George Clinical. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

Keywords: George Clinical, Memphis , Clinical Trial Specialist, Healthcare , Memphis, Tennessee

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