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