What are the responsibilities and job description for the Clinical Operations Specialist position at GForce Life Sciences?
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