Note: The job is a remote job and is open to candidates in USA. Advarra is a clinical research organization and technology provider focused on advancing human health through ethical review services and connected clinical research solutions. The Senior Documentation and Project Management Specialist manages operational and process-improvement projects, develops and maintains instructional documentation, serves as a subject matter expert for IRB Operations, and supports quality and client-service activities.
Responsibilities
- Works with Sr Director, Training, QC & Client Experience to identify strategies and methods to achieve organizational goals
- Communicate with Management team to identify and implement strategies to improve quality, efficiency, and service standards and/or operational procedures
- Lead and manage routine and non-routine projects
- Develops, updates and maintains department instructional documents
- Maintains and manages IRB Operations Document Inventory
- Serves as SME for IRB Operations teams (e.g. Client Services) for operational issues
- Available as SME for internal and external inquiries
- Assists Client Experience, Client Success and QA with all client questions related to Client Services processes
- Coordinates with other SMEs, Team Leads and Managers to ensure consistency in responses and approach
- Demonstrates an advanced understanding of various types of protocol and site submissions
- Review/analyze complete submissions for quality, customer satisfaction, and to ensure process followed
- Maintains a high level of quality and attention to detail
- Completes work within expected turnaround times
- Attends conferences and workshops
- Leads presentations in various meetings, as needed
- Completes assigned training in a timely manner
Skills
- • Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility
- • Five (5)+ years of demonstrated proficiency in related role
- • Experience fulfilling responsibilities with team-wide visibility and impact, such as routinely providing training and guidance to team or other groups
- • Demonstrated ability to perform as an expert in operational processes and provide appropriate insight to junior staff
- • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- • Proficiency in SharePoint
- • Experience with document version control and tracking
- • Ability to adapt to changing technologies and document management systems
- • Sit or stand for extended periods of time at stationary workstation
- • Regularly carry, raise, and lower objects of up to 10 Lbs
- • Learn and comprehend basic instructions
- • Focus and attention to tasks and responsibilities
- • Verbal communication; listening and understanding, responding, and speaking
- • Bachelor's degree or five (5) years of equivalent experience in clinical research or healthcare setting preferred
Benefits
- This position may also be eligible for a variable bonus in addition to base salary
- Health coverage
- Paid holidays
- This role is open to candidates working remotely in the United States
Company Overview