University of Chicago

Research Project Manager

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Job Summary: Research Project Manager 

The Research Project Manager will be a key team member of the UCM-based enrollment site of the All of Us^SM Research Program: Precision Medicine Initiative funded by the National Institutes of Health (NIH) as well as future related bio-banking/epidemiology studies.  Precision medicine is an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, environment, and lifestyle.  By enrolling nationally one million or more participants who provide Participant Provided Information, Electronic Health Record data, biospecimens, physical evaluations, and permission for re-contact, All of Us will have the scale and scope to enable research for a wide range of diseases, both common and rare, as well as increase our understanding of healthy states.  This position is a key contributor within the Illinois Consortium which is responsible for recruiting 150,000 participants over 5 years.  Responsibilities are to oversee all aspects of participant enrollment efforts in order to meet the yearly goals, determine methods to enhance recruitment yields, facilitate participant engagement, and plan for and enact best practices to ensure result dissemination to participants. 

The Research Project Manager will be responsible for orchestrating the day-to-day research project in accordance with stringent NIH-defined protocols.  Duties include managing activities associated with the creation and implementation of participant recruitment.  Recruitment strategies must be designed to enhance enrollment in biomedical &/or social-behavioral research studies considered very complex by the inclusion of several challenging factors such as: multiple investigators, teams, sites, and sub-contracts; large volumes and diversity of participants; and longitudinal assessments/interventions.  The incumbent will be responsible: for creating, implementing, monitoring & updating recruitment project plans; facilitating meetings and training sessions with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained.  Other responsibilities include: monitoring, analyzing & reporting research study progress in a quantifiable manner; resolving &/or escalating issues in a timely manner. 

All participant recruitment activities are expected to be completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

Please note: The selected candidate will need to be flexible regarding their work schedule.  There will be times that evening and/or weekend work will be required to attend community events, recruitment events, meetings, etc.

Specific Responsibilities:

Recruitment & Enrollment

·         Manages the creation and implementation of a recruitment plan including feasibility discussion planning associated with research studies involving human subjects ensuring the protection of their safety, rights, and welfare while meeting the study recruitment/enrollment goals and objectives.

·         Acts as a Subject Matter Expert (SME) in regard to recruitment/enrollment for human subject-based research studies including bio-banking and epidemiologic projects; determines, interprets and applies rules and regulations (UofC, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study recruitment and enrollment activities ensuring appropriate compliance.

·         Acts as liaison between research staff and internal/external regulatory and oversight groups (UChicago’s and NIH IRBs, sponsors, government agencies, etc.), program promoters, etc. to resolve issues and offer recommendations to facilitate and expedite study recruitment and enrollment while ensuring compliance.

·         Work with study investigators to facilitate participant engagement and recruitment focusing on community partnerships, minority and underrepresented participants in racial, ethnic, and gender groups historically excluded from participation, who face issues related to health equality, as appropriate.

·         May act as an additional health interviewer to help screen participants to assess study eligibility and help conduct the participant exams.   

·         Develops protocol specific recruitment communications and other tools.

Administration

·         Manages all recruitment, enrollment and advertisement submission, documentation, and reporting processes recommending alternatives to ensure compliance and approval.

·         Creates and maintains assessment tools, metrics, key performance indicators (KPI), etc.; analyzes data; recommends changes and adaptation in strategy, protocol, etc. that will maximize recruitment success, relevance to research, and customer satisfaction.

·         Assists PIs in developing statistical methods & models to analyze and report recruitment & enrollment data based on study requirements.

·         Creates data for use in grant submissions and new proposals for research including financial support.

·         Ensures appropriate and timely compliance with associated local, state, & federal regulatory guidelines, requirements, & laws; & research protocols.

·         Creates and provides guidance and training to staff to ensure compliance with complex, highly specialized rules and regulations associated with research studies involving human subjects.

·         Partners with internal/external staff regarding community outreach engagement initiatives related to research including the development and/or review of community based education programs, print and web materials, and training competencies regarding research, recruitment, participation, and retention.

Supervision

·         Trains, directs, assigns duties to & supervises research staff, students, residents &/or fellows.

·         Acts as a mentor in regard to education of junior staff.

Miscellaneous

·         Performs other duties as assigned.

Minimum Qualifications

Required:

Master’s Degree in Epidemiology, Public Health or closely related field AND 3 years of post-degree research project management experience OR a Doctoral-level degree in Epidemiology, Public Health or closely related field and interest and knowledge in large study management (can involve thesis and dissertation work relevant to recruitment and data).

Preferred:

Doctoral-level degree in Epidemiology, Public Health or closely related field and two years of post-doc experience including but not limited to large study management OR Master’s degree in Epidemiology, Public Health or closely related field AND 5 years of post-degree research project management experiences

Must complete UChicago's IRB CITI training before interacting with any participants & must re-certify every 3 years.

This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract.  Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance. 

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