Clinical Research Project Manager

Department: Med-ISGMH
Salary/Grade: EXS/7

Job Summary

The Institute for Sexual and Gender Minority Health and Wellbeing (ISGMH) is seeking applicants for a Research Project Manager to oversee the RADAR project's biomedical team. This position 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).

ISGMH: The Institute for Sexual and Gender Minority Health and Wellbeing (ISGMH) at Northwestern University was created in 2015 to be a leader in research that improves the health and wellbeing of the sexual and gender minority (SGM) community and foster understanding of the development and experience of SGM people. The institute provides unique opportunities for high-level research and training for the next generation of SGM scholars, and it utilizes innovative modalities to disseminate knowledge widely to the SGM community, the public at large, scholars, service providers, educators, and policymakers.

This position is fully in-person and is primarily based off campus at the Center on Halsted (COH), with some hours at the main ISMGH location, 625 N. Michigan Ave, depending on project need. Center on Halsted is an LGBTQ community center located in Chicago's Lakeview neighborhood, dedicated to enhancing community and securing the health and well-being of the LGBTQ people of Chicagoland. 625 N. Michigan Ave. is home to the Institute for Sexual and Gender Minority Health and Wellbeing (ISGMH).

This is a 1-year term position with the opportunity for renewal based on performance and funding availability. If interested, please submit a resume and cover letter.

Please note: Weekend and evening hours will be required. This position will be based off campus, at the Center on Halsted.

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. Collaborating with biomedical 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.
• 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. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
• 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.

Data

• Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project 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.

Finance

• May create &/or manage research study budget which may include deciding on & approving expenditures of funds based on budget.
• Monitors accounts.
• Negotiates prices & specifications with vendors.
• Purchases supplies, materials, equipment & services.
• Ensures appropriate allocation & compliance.
• Invoices study sponsors for study tests/procedures.
• Coordinates & participates in budgetary negotiations with industry sponsors.

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.)

• Phlebotomy Experience
• Experience working with LGBTQ+/SGM/TGNC/gender-expansive individuals, specifically youth.
• Familiarity with basic computer programs including Microsoft Excel/Word/Ppt,
• Adobe, Google
• Experience handling and processing biospecimens & sending them via medical
• courier services.
• 2+ years direct service experience working with clients/participants in clinical and/or other community setting.

Preferred Qualifications: (Education and experience)

• Phlebotomy Certification
• HIV/STI pre-/post-test counseling and rapid test administration

Preferred Competencies: (Skills, knowledge, and abilities)

• Experience working with individuals living with and/or vulnerable to HIV/AIDS
• Experience working with people who use drugs.
• Familiarity with Chicago-area social services and resources related to youth, health, housing.
• Phlebotomy experience helpful but not required.
• Experience using research database software including REDCap and Qualtrics
• Familiarity using social media platforms including Facebook, Instagram, and dating apps.

Target hiring range for this position will be between $63,079 - 88,705 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.

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. Click for information on EEO is the Law.

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