Research Project Manager

Department: MED-Ctr for Community Health
Salary/Grade: EXS/7

Job Summary

Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million-dollar budgets. Ensures completion of contract requirements & client specifications. 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. May co-author scientific papers for presentation & publication & coordinates 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), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).

Project Description:

This position will be focused on a new research study, Healthy Moms/Mamis Saludables: Partnership to Prevent Maternal Diabetes in US Home Visiting Programs. This study is funded by the Patient-Centered Outcomes Research Institute and is a five-year project conducted in collaboration with Cal-Poly University and Brown University. The study is a randomized controlled trial, in which pregnant individuals and new parents will be randomized to receive either a lifestyle intervention targeting healthy eating, activity, and weight or a lifestyle intervention and the provision of Medically Tailored Meals (MtM).

The Research Project Manager will be responsible for overseeing all aspects of this clinical trial, including but not limited to (a) regulatory [e.g., IRB] requirements, (b) ensuring study protocols for intervention delivery and data collection are adhered to, (c) managing a team of outreach and intervention support staff, (d) developing relationships and working closely with community-based home visiting programs in multiple states where the intervention is delivered, and (e) collaborating with other study sites [Cal-Poly, Brown].

This project will be with the Mothers & Babies Program (https://www.mothersandbabiesprogram.org/) and housed in the Center for Community Health (CCH) which provides a home for a diverse array of academic investigators, community partners, and staff members, who are all dedicated to promoting health through the conduct and dissemination of community-engaged research. As a center with a presence in the both the Institute for Public Health and Medicine (IPHAM) and Northwestern University Clinical and Translational Sciences Institute (NUCATS), CCH provides community and stakeholder engagement infrastructure across the research spectrum. Mothers and Babies is an evidence-based, post-partum depression prevention intervention that has been delivered largely in home visiting programs. This project will also integrate some stress management approaches from Mothers and Babies into the lifestyle intervention. Within the Mothers and Babies lab, there is another similar project focused on promoting cardiovascular health among familied enrolled in home visiting programs.

Specific Responsibilities:

Technical

• Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
• Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
• Oversees completion of study activities per protocol.
• Ensures that 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.
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.

Administrative

• Analyzes, evaluates & interprets data to determine relevance to research.
• Assists PI in developing statistical methods & models to analyze & report data based upon study requirements.
• Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
• Creates data for use in grant submission & develop new proposals for research including obtaining financial support.
• Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
• Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.

Finance

• May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
• Purchases supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance.

Supervision

• Trains, directs, assigns duties to & may supervise lab EEs, students, residents &/or fellows.
• Acts as a mentor in regard to education of junior coordinators.

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications: (Education, experience, and any other certifications or clearances)

• 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; OR appropriate combination of education and experience and 3 years' research study or other relevant experience.
• Supervisory or project management experience required.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Exceptional organizational skills, time management efficiency, and personal accountability
• Proficient with Microsoft Office software and database management
• Excellent interpersonal and supervisory skills

Preferred Qualifications: (Education and experience)

• Experience working with home visiting programs
• Experience managing clinical trials, ideally those delivered in community-based settings

Preferred Competencies: (Skills, knowledge, and abilities)

• Bilingual (Spanish/English)

Target hiring range for this position will be between $63,079 - 78,849 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

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