Project Manager II - NCCT Study Start-up Navigator

Department:

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

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Varies

Pay Range

$33.05 - $49.60

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.

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