Department: MED-Medical Social Sciences Salary/Grade: EXS/8
Manages all activities associated with new and highly complex programmatic initiatives in the field of culinary medicine inclusive of research/outcomes; education initiatives; grant-writing; training; and dissemination. The CUH program assesses the feasibility, acceptability, and efficacy of the Cooking Up Health (CUH) culinary medicine elective that is offered to allied health professionals and medical students at Northwestern University's Feinberg School of Medicine and other academic programs. The elective included a combination of applied nutrition didactics, chef-led culinary sessions, and service-learning, in which students translated nutrition and health connections to elementary school children in at-risk communities. This program of research may provide evidence to support the widespread integration of CUH into medical education and has the potential to prepare medical students to properly advise patients on nutrition to combat the rising rates of obesity, diabetes, and preventable diseases related to nutrition.
Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner.
Supports project and curriculum development efforts including running focus groups, management of learning management systems (LMS) and curriculum production, faculty training and outreach.
May co-author papers for presentation and publication, coordinate writing, submission & administration of grants. Ensures that all study activities are 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).
Under direction of the Executive Director of the Osher Center for Integrative Medicine at Northwestern University, this manager will organize, plan, and control the workflow of the Cooking Up Health initiative offered to allied health professionals and medical students at Northwestern University’s Feinberg School of Medicine.
Additionally, this manager will coordinate and manage relationships with outside partners including the Chicago Public School system and strategic collaborators. This individual is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. In addition, this manager will ensure successful operational tracking of philanthropic funds, Council management/development, and programmatic initiatives. Additionally, this position works extensively with the Osher Collaborative (comprised of Harvard University, Karolinska Institutet, University of California, San Francisco, University of Miami, Vanderbilt University), leadership to create and nurture collaborations and partnerships via education, research, and clinical care.
Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
Directly involved with study start-up, implementation, conduct, and close-outs.
Oversees completion of study activities per protocol. Guides clinical research coordinators in collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
Manages day to day activities of clinical research teams and oversees interaction with critical clinical partners.
Ensures that the conduct of study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
Works directly with the CRO’s Quality Control Manager on the development of standard operating procedures for clinical staff and also monitors compliance with procedures.
Serves as contact between clinical staff and multiple NM and NU departments on issues related to clinical research coordination.
Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
Oversees recruitment and management of clinical research staff.
Completes applications and obtains appropriate approvals from various groups (CSRC committee, CRU, IBS, Pharmacy, etc.) for all necessary study-start-up functions.
Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external projects and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.
Ensures appropriate allocation & compliance.
Invoices study sponsors for study tests/procedures.
Coordinates & participates in budgetary negotiations with industry sponsors.
Works directly with Clinical Research Unit (CRG) in development of applications, nursing orders and patient flow sheets for research studies involving the CRO. Serves as main CRG contact throughout study development and until study completion.
Trains, directs, and assigns duties to supervise clinical research coordinators and nursing staff. Assists in training of regulatory team and data assistants.
Acts as a mentor in regard to education of junior coordinators.
Monitor federal regulatory agency requirements related to clinical research training. Provide training to staff regarding federal, state and institutional requirements. Monitor skill level of staff in relation to non-procedural issues and provide instruction where necessary. Serve as a resource to the clinical trials staff, evaluating opportunities to improve productivity and operational efficiency.
Provides training on any new office policies and procedures.
Supervises interactions with study sponsors and CRO monitors. Directs weekly prep meetings for sponsor/monitor visits.
Ensures the clinical functioning of the office is efficient by providing supervision of day to day activities of multiple teams of clinical research coordinators (CRCs), Clinical Research Nurses (CRNs), and data assistants. Responsible for interviewing, hiring and evaluating the aforementioned staff. This position will manage administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators. Assists with internal audits of research charts to ensure compliance with protocol requirements.
Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to Cooking Up Health initiative and other programs. Will work closely with Cancer Center leadership to implement policies, procedures, and training for partners such as the VA, Lake Forest, Cadence, and any other sites NM expands to.
Directs actions to ensure high quality clinical research and operational standards are maintained across all programs and initiatives.
Performs other duties as assigned
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related.
Supervisory or project management experience required.
Must complete NU's IRB CITI training before interacting with any participants & must recertify every 3 years.
Minimum Competencies: (Skills, knowledge, and abilities.)
Excellent written and oral communication skills
Strong organization and interpersonal skills.
Computer expertise include being literate in Microsoft Office, Internet and database use.
Fund and project management skills.
Excellent writing skills, communication, web design, fund management, project management experience.
Preferred Competencies: (Skills, knowledge, and abilities)
Excel with Pivot Tables, Microsoft Office Suite, G-Suite, Cision, Mailchimp, Hootsuite, Squarespace, and Canva.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 38362
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.