Senior Documentation and Project Management Specialist

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $81.9k - $150.2k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

🏥 Healthcare

💼 Consulting

☁️ SaaS

Healthcare • Consulting • SaaS

Advarra is a provider of integrated regulatory oversight and clinical trial technology, combining independent IRB review and compliance services with enterprise SaaS platforms (including Braid, OnCore, Clinical Conductor, eReg, and eSource). The company delivers operational intelligence, AI-powered protocol design and automation, site collaboration, study startup and enrollment tools, and strategic enablement services to sponsors, CROs, research sites, and institutions to improve efficiency, compliance, and patient safety across the clinical trial lifecycle.

📋 Description

• Work with the Sr Director, Training, QC & Client Experience to identify strategies and methods for achieving organizational goals • Communicate with the Management team to identify and implement strategies to improve quality, efficiency, service standards, and operational procedures • Lead and manage routine and non-routine projects • Develop, update, and maintain department instructional documents • Maintain and manage the IRB Operations Document Inventory • Serve as a subject matter expert for IRB Operations teams, including Client Services, on operational issues • Serve as an SME for internal and external inquiries • Assist Client Experience, Client Success, and QA with client questions related to Client Services processes • Coordinate with SMEs, Team Leads, and Managers to ensure consistency in responses and approach • Demonstrate advanced understanding of protocol and site submission types • Review and analyze complete submissions for quality, customer satisfaction, and process compliance • Complete work within expected turnaround times • Attend conferences and workshops • Lead presentations in meetings as needed • Complete assigned training in a timely manner

🎯 Requirements

• 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 a 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 • Ability to work remotely in the United States • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects of up to 10 lbs • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities • Verbal communication, listening and understanding, responding, and speaking

🏖️ Benefits

• Variable bonus eligibility • Health coverage • Paid holidays • Reasonable accommodation for applicants with disabilities • Inclusive and collaborative workplace environment