Clinical Trial Oversight Project Manager, National Center for Clinical Trials (NCCT)

Advocate Aurora Health is a leading nonprofit health system in the United States, and they are seeking a Clinical Trial Oversight Project Manager to join their National Center for Clinical Trials. This role involves managing the clinical trial feasibility review process and overseeing trial performance to ensure the successful execution of clinical trials.

Responsibilities:

• Assesses overall feasibility of clinical trials as they are presented to NCCT and works with other functional areas to gather information and render a decision as to whether trials will move forward in the negotiation process
• Works with informatics team to analyze availability of patient cohorts and potential subject accrual challenges given competing trials
• Reviews potential trial opportunities and distributes information about the trials to functional areas and leaders to analyze potential participation
• Works with service line and site leaders to assess scientific merit of trials, feasibility, site readiness and resources
• Evaluates all potential sites for activation working with site teams, ancillary services team, study teams and site resource managers. Factors to be taken into account for site assessment include staffing, ancillary services, resources/equipment, geographical location with respect to eligible patients, interested PIs at potential sites and sponsor interest in number of sites
• Works with Recruitment, Call Center and Data Coordinating Center to develop patient matching, recruitment and study conduct plans
• Reviews ongoing and upcoming trials and works with leadership to prioritize competing trials
• Works with IT team to assess IT needs for trials. Facilitates and attends site initiation visits
• Responsible for outreach to applicable physicians, care teams, etc to gain valuable information
• Maintain working knowledge of clinical trials within research portfolio. Conducts preliminary review of central needs for trials
• Connects study staff members with training resources as necessary for compliance with policies
• Monitors progress of the clinical trial until completion ensuring accrual, study activities and quality measures are met
• Liaises with regulatory to monitor amendments, personnel changes, etc. Liaises with sponsor, investigator(s) and site staff throughout trial
• Monitors resource demands throughout trial
• Supports the deployment of coordinators and Advanced Care Providers in conjunction with Site Resource Managers to sites as needed for study conduct
• Performs other related duties incidental to the work described herein

Requirements:

• Master's degree related to project management and evaluation, such as Epidemiology, Public Health, Psychology, or Sociology and four years of relevant administrative and medical experience in research projects or other health-related activities; or, an equivalent combination of education and experience
• Two years' experience in a supervisory capacity
• Must have 4+ years managing projects and/or processes
• Must have 2 years in a supervisory capacity
• Must have 5+ years of experience working with clinical trials
• 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