Senior Documentation and Project Management Specialist

Job not on LinkedIn

🔥 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

💼 Consulting

📦 Logistics

📣 Marketing

Consulting • Logistics • Marketing

Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.

📋 Description

• Identify strategies and methods to achieve organizational goals • Communicate with management to identify and implement strategies improving quality, efficiency, service standards, and operational procedures • Lead and manage routine and non-routine projects • Develop, update, and maintain departmental instructional documents • Maintain and manage the IRB Operations Document Inventory • Serve as a subject matter expert for IRB Operations teams on operational issues • Respond to internal and external inquiries as a subject matter expert • Assist Client Experience, Client Success, and QA with client questions related to Client Services processes • Coordinate with subject matter experts, team leads, and managers to ensure consistency in responses and approach • 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 • Coordinate with department managers on daily workload reassignments as needed

🎯 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 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 culture