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Project Manager II - NCCT Study Start-up Navigator jobs in United States
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Advocate Aurora Health · 2 days ago

Project Manager II - NCCT Study Start-up Navigator

Advocate Aurora Health is the third-largest nonprofit, integrated health system in the United States, and they are seeking a Project Manager II for the NCCT Study Start-up Navigator role. This position will manage the clinical trial intake process and facilitate study start-up activities while collaborating with cross-functional teams.
Health Care

Responsibilities

Serves as the initial contact for clinical trials as they are presented to NCCT and works with other functional areas to gather necessary information to support the decision process in whether trials will move forward in the negotiation process
Facilitates the study start-up activities partnering with cross-functional teammates internally and externally and will support ongoing submission needs in REDcap, OnCore and Huron related to contract and/or budget amendments
Receives study start-up material (regulatory, budget and contract) from Sponsor/CRO/Principal Investigator or Department
Conducts study intake entering relevant information into systems (e.g., REDCap) for review by other functional leaders
Assesses potential availability of appropriate Principal Investigator(s) across Enterprise
Submits Confidentiality Disclosure Agreement (CDA) into system for processing by contracts team and facilitates/monitors completion within short timeframes
Works with Informatics team to collect information regarding availability of patient cohorts for feasibility questionnaire completion
Completes feasibility questionnaire with informatics and service line/department/PI feedback
Facilitates site qualification visits and attends if virtual and as needed
Triages received study materials to the Study Oversight Project Manager for further feasibility review
Builds OnCore shell, completes OnCore REDCap Intake Form and notifies central teams to begin start-up activities including regulatory, contract, and budget-related tasks
Submits draft CTA/work order, budget in systems to route to OCR Pre-Award for review and processing
Conducts quality checks in systems (i.e., OnCore, ClinCard, Huron)
Helps teams identify and provide solutions to navigate start-up barriers, escalating to leadership as appropriate
Ensures all start up activities are complete prior to activating the study
Other intake-related duties as assigned

Qualification

Clinical trial management systemsClinical trial operationsMicrosoft OfficeProject managementCommunicationOrganizational skillsTeamwork

Required

Bachelor's Degree with Project Management focus
2 years of experience managing projects and/or processes
1 year in a supervisory capacity
Working knowledge of clinical trial management systems and electronic medical records
Detailed understanding of clinical trial operations and challenges from the site perspective
Experience in leading teams and in decision-making role(s)
Excellent written and verbal communication skills
Excellent organizational skills and attention to detail
Demonstrated ability to work independently as well as in a team environment
Proficiency with Microsoft Office, Microsoft Excel and Microsoft PowerPoint

Benefits

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Company

Advocate Aurora Health

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Advocate Aurora Health is a Healthcare

Funding

Current Stage
Late Stage
Total Funding
$10.17M
Key Investors
National Cancer Institute
2022-12-02Acquired
2019-08-20Grant· $10.17M

Leadership Team

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Don Fosen - CISM, HCISPP
Chief Technology Officer
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Jon Kluge
Chief Operating Officer, Senior Vice President, Advocate Aurora Medical Group
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Company data provided by crunchbase