Clinical Trials Associate

Location: Morrisville, North Carolina, United States

Notice

This position is no longer open.

Requisition Number: 545

Position Title: Clinical Trials Associate

External Description:

The Clinical Trials Associate is a full time position responsible for ensuring all assigned projects for Clinical Operations are performed timely and accurately while interfacing directly with in-house personnel and field employees. The Clinical Trials Associate develops required tools, forms and documents, and provides additional administrative support for Clinical Operations.

RESPONSIBILITIES:

  • Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros
  • Assist Clinical Operations personnel with study initiations and special projects
  • Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents
  • Manage document control functions, including maintaining Master List of paper and electronic documents and media generated and distributed
  • Audit and resolve issues of redundancy, currency and consistency of documents on shared drive and portals
  • Maintain and quality audit to assure most recent revisions of documents are on portals and server
  • Assist project team (CRAs, Lead CRAs and Project Managers, etc.) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts
  • Assist with maintenance of trial master file documents as appropriate and needed
  • In liaison with the CRAs, manage preparation of documents for grant payments
  • Regularly review the status of key documentation in the file for SOP compliance
  • Provide support to Clinical Operations Manager on an ad hoc basis.
     
    OTHER SKILLS AND ABILITIES:
  • Excellent written and verbal communication skills
  • Ability to work independently and as a team member
  • Strong interpersonal skills in a fast-paced and rapidly changing environment
  • Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
  • Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
  • Strong organizational skills, including ability to develop naming conventions and filing architecture
  • Advanced skills in MS Office applications including Microsoft Word, Access, Excel, PowerPoint and Publisher.
  • Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
  • Excellent spoken and written English skills as well as fluency of the language of the country of location 


REQUIREMENTS:

  • Four-year college curriculum or university degree, life science preferable
    • At least one years’ experience in office administration or similar position

#LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Clinical Trials Associate

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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© Worldwide Clinical Trials 2019

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.