Clinical Operations Specialist

Clinical Operations Coordinator - Documentation/Onboarding

12-month Contract

Remote - CST or EST Hours

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.