Clinical Operations Associate II

  • Location: NJ, United States
  • Type: Contract
  • Job ID: 10356
  • Work Setting: On-Site
  • Posted: May 28, 2026
  • Closing Date: June 14, 2027
  • Tax Status: W2
Clinical Operations Coordinator – Documentation/Onboarding
12-month Contract
Remote – CST or EST Hours
Pay rate: Up to $40 per hour, based on experience. 

 
Responsibilities
  • Drive the day-to-day activities to ensure the accuracy, and maintenance of documents used within the Clinical Operations Management team. (e.g., Job Aids, procedures, training presentations)
  • Receive notification that a new or revised document is to be developed.
  • Facilitate Kick-off meetings for Job Aids and meetings for Assessment Reviews and Agnostic Plans.
  • Provide subject matter expert (SME) with the appropriate templates for a new document or an editable version of the document to be revised.
  • Review documents for adherence to the template and completeness of the content by utilizing source materials to ensure that the content is reflective of the process being documented.
  • Assign procedure numbers for new document requests and ensure documents are versioned up for existing documents before implementation.
  • Collaborate with subject matter experts by ensuring their understanding of their responsibilities and timelines.
  • Advise SMEs of the approval pathways for the document packages based on the new or revised content.
  • Prepare approved document packages for implementation.
  • File the approved document packages in the appropriate development folder on the Clinical Operations Process Management repository, ensuring all effective dates are updated and converted to *pdf, if applicable.
  • Responsible for completing all activities on the CM Onboarding Checklist, which includes but not limited to:
  • Obtaining laptops for new Clinical Management employees
  • Gaining system access for new Clinical Management employees
  • Ensuring new CM employees are on appropriate distribution lists
  • Requesting access for the Partnership Portal
  • Attending Onboarding Sessions to provide administrative support (e.g., adding links to chats and ensuring new employees have access)
 
Qualifications
  • Bachelor’s Degree
 
Required Skills
  • Experience with PC-Windows, word processing, and electronic spreadsheets required
  • Knowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations required
  • Clinical trials support or pharmaceutical industry experience required
  • Ability to work effectively within a team matrix as well as independently
  • Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
  • Experience and knowledge of Sharepoint
  • Ability to travel as required to carry out responsibilities
  • Experience of Visio is a plus
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