Remote Senior Documentation & Project Management Lead

Advarra; Northern (KY); Hybrid; USD 82,000 - 150,000; Full time

Job summary

Advarra, a leader in clinical research, seeks a Senior Documentation and Project Management Specialist to serve as a department resource for operational issues, identify opportunities for process improvements, and help develop instructional documents. The role coordinates with department managers to reassign daily workloads as needed and drives project execution.

The position requires a bachelor’s degree (or 5+ years in a related field), CIP certification (or within 1 year), and 5+ years of

Qualifications

• Bachelor’s degree or five years of equivalent experience in clinical research or healthcare setting preferred.
• Certified IRB Professional (CIP) or attainment of CIP within one 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

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.
• 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

Operational excellence

Training & guidance

Project management

Quality focus

Education

Bachelor's degree

Certified IRB Professional (CIP) or CIP within 1 year

Tools

Microsoft Office Suite

SharePoint

Job description

Advarra, a leader in clinical research, seeks a Senior Documentation and Project Management Specialist to serve as a department resource for operational issues, identify opportunities for process improvements, and help develop instructional documents. The role coordinates with department managers to reassign daily workloads as needed and drives project execution.

The position requires a bachelor’s degree (or 5+ years in a related field), CIP certification (or within 1 year), and 5+ years of