Sr Documentation and Project Management Specialist

Company Information
At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.
Company Culture
Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions.
Knowing the impact of our work on trial participants and patients, we act with urgency and
purpose to advance clinical research so that people can live happier, healthier lives.
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.
Job Overview Summary
The Senior Documentation and Project Management Specialist functions as a departmental source for operational issues, identifies opportunities for and implements changes to facilitate process improvement, and participates in development/revision of instructional documents. In addition, the Senior Documentation and Project Management Specialist completes projects as defined by management and coordinates with department managers on daily workload reassignments, as needed.
Job Duties & 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
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
Bachelor’s degree or five (5) years of equivalent experience in clinical research or healthcare setting preferred
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

Preferred Qualifications

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
Physical and Mental Requirements
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
Advarra is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information, or any other status or characteristic protected by federal, state, or local law.
Pay Transparency Statement
The base salary range for this role is $81,903 - $150,156. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.