Clinical Research Project Manager

Department: MED-Ctr Tran Metabolism Health
Salary/Grade: EXS/7

Job Summary

The Clinical Research Project Manager supports Dr. Tamara Isakova's research within the Center for Translational Metabolism and Health (CTMH). CTMH is one of 18 research centers housed within the Institute for Public Health and Medicine (IPHAM). The successful candidate will join a dedicated research team and will manage a small team. Bilingual candidates (English and Spanish) are strongly encouraged to apply. This position conducts work within clinical research settings and the successful candidate will need to be on campus to perform the research.

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. Collaborates with research staff (e.g., Principal and Sub Investigators, research coordinators, research administrators), asses participant eligibility requirements against protocol 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.

Administrative

• 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/submitted in a timely manner.

Data

• Manages project data including processing, entry, quality checks for 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.
• Creates source documents/eCRFs in REDCap (as applicable)
• Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.

Finance

• Monitors accounts.
• Negotiates prices & specifications with Sponsors, CROs, and other vendors.
• Purchases supplies, materials, equipment & services.
• Coordinates with research administrators to invoices study sponsors for study tests/procedures.
• Coordinates & participates in budgetary negotiations with industry sponsors, CROs, and institutional staff.

Supervision

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

Minimum Competencies: (Skills, knowledge, and abilities.

• Proficiency with MS Outlook, Teams, SharePoint, Excel, Box, and REDCap
• Proficiency in phlebotomy (with or without certification)
• Strong organizational skills
• Strong communication skills
• Strong work ethic
• Able to work independently and with others
• Strong leadership

Preferred Qualifications: (Education and experience)

• CCRP or ACRP certified, strong familiarity with Title 21 and 45 of CFRs

Preferred Competencies: (Skills, knowledge, and abilities)

• Bilingual (i.e, English and other language)

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 strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness. More information can be found on the COVID-19 and Campus Updates webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

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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