Clinical Operations Specialist

Clinical Operations Coordinator - Documentation/Onboarding12-month Contract Remote - CST or EST HoursResponsibilitiesDrive 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 employeesGaining system access for new Clinical Management employeesEnsuring new CM employees are on appropriate distribution listsRequesting access for the Partnership PortalAttending Onboarding Sessions to provide administrative support (e.g., adding links to chats and ensuring new employees have access)QualificationsBachelor’s DegreeRequired SkillsExperience with PC-Windows, word processing, and electronic spreadsheets requiredKnowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations requiredClinical trials support or pharmaceutical industry experience requiredAbility to work effectively within a team matrix as well as independentlyProficient in Microsoft products (Outlook, Word, Excel, PowerPoint)Experience and knowledge of SharepointAbility to travel as required to carry out responsibilitiesExperience of Visio is a plus