ESSENTIAL FUNCTIONS
Leadership & Management:
Oversee all aspects of the Regulatory team to provide timely and quality service to sponsors, CROs and all internal departments at Centricity
Hire, manage, and lead Regulatory team, including holding including people management tasks from PTO and timecard approvals to professional development Manage administrative responsibilities for the source team, including time off approval, PTO coverage, weekly meeting agendas, and team resource maintenance
Oversee onboarding of new staff and mentor junior team members in accordance with the established departmental procedures and SOPs
Ensure continued quality control across the department
Collaborate with internal departments to coordinate start-up activities, amendments and maintenance of Investigator Site Files
Lead regular team meetings and individual team check-ins to review priorities, objectives, metrics and milestones
Work with senior leadership to track issues, quality trends, compliance and data integrity to guide data-driven improvements in the department
Individual Contribution:
Complete Early Phase Regulatory submissions (when required) – support completion of Request For Information (RFI), Sponsor, regional Health authorities, and Ethics documentation requirements
Complete Late Phase local or central REB or IRB submissions and Sponsor documentation requirements and delegate to site when appropriate (see table: Central vs. Site Regulatory Obligations)
Liaise with the Sponsor and Research Ethics Board (REB) or Research Ethics Committee (REC) or Institutional Review Board (IRB) to facilitate prompt review and approval of study documents
Provides input on budget requirements including items such as diagnostic imaging, local labs, subject stipend, etc.
Delegate roles and responsibilities in conjunction with managing additional regulatory obligations i.e. Lab & Diagnostics set up, IIT Trial Submissions
Facilitate translation requirements as needed
Responsible for timely recruitment material approvals with Sponsors, CROs and REBs/IRB
Collaborate with all internal departments regarding study start-up activities to ensure efficient study starts and goal of achieving First Patient First Visit (FPFV)
Additional ongoing administrative duties such as managing to ensure current CVs and medical licenses are obtained and up to date
Maintain central regulatory documents
Attend and update Centricity Research management team at scheduled meetings and address any regulatory concerns identified
Provide support, knowledge, and assistance as needed to any research staff or Sponsor/CRO to help clarify or address any Regulatory questions
Other duties and supervisory responsibilities as assigned