Project Manager II - NCCT Study Start-up Navigator

Department:

85296 Wake Forest University Health Sciences - WF Clinical Trial Methods Center of Excellence

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Varies

Pay Range

$32.45 - $48.70

The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials−greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence.

The Clinical Trial Methods Center (CTMC) has been established within the Wake Forest University School of Medicine to provide the necessary tools and expertise that the NCCT will access and apply to deliver many of its core services.

This position will be part of a team that will report to leadership in the NCCT and will manage the clinical trial intake process.  

Education/Experience

Bachelor’s Degree with Project Management focus; 2 years of experience managing projects and/or processes with 1 year in a supervisory capacity or an equivalent combination of education and experience. 

Essential Functions

Study Start-Up Navigator (SSUN) 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. The SSUN will facilitate 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.

Skills/Qualifications

• Must have 2 years managing projects and/or processes.
• Must have 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.

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About Us

Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.

Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children’s Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.

Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing – for all.

It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process.  Thanks in advance for your flexibility.

About The Team

Mission, Vision and Culture Commitments

Mission

To improve health, elevate hope and advance healing – for all.

Vision

To be the first and best choice for care. 

Culture Commitments

We create a space where all Belong

We Work as One to make great things happen

We earn Trust  in all we do

We Innovate to better the now and create the future

We drive for Excellence – always

Our Commitment To You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• Premium pay such as shift, on call, and more based on a teammate's job
• Incentive pay for select positions
• Opportunity for annual increases based on performance

Benefits And More

• 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

About Advocate Health

Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.