Manager, Center Clinical Research

Department: MED-NU-CATS Institute
Salary/Grade: EXS/9

To ensure full consideration, applicants must submit a resume and cover letter as part of their application.

Job Summary:

The Northwestern University Clinical and Translational Sciences (NUCATS) Institute is part of the Feinberg School of Medicine. NUCATS' mission is to accelerate innovative and inclusive clinical research discoveries to improve human health for all, and for all communities. Our dynamic team is composed of faculty and staff colleagues with expertise in a wide variety of domains, including: clinical research infrastructure (e.g., regulatory, budget/finance), bioinformatics & data science, biostatistics, community-engaged research, education & career development, team science, etc.

The Northwestern University Clinical and Translational Sciences (NUCATS) Institute seeks qualified candidates for the position of Manager, Center for Clinical Research (CCR). This management role is integral to the NIH-funded Clinical and Translational Science Award (CTSA) program at Northwestern and is responsible for advancing strategic initiatives that strengthen clinical research operations, regulatory compliance, and financial management to support research excellence.

The Manager will provide comprehensive oversight of CCR operations, including the CCR Regulatory and Finance service lines, ClinicalTrials.gov compliance, and facilitation of FDA IND/IDE regulatory needs - ensuring alignment with institutional priorities and federal requirements. In addition, the Manager will lead workforce development initiatives, mentor research teams, and foster collaboration across the Feinberg School of Medicine, Northwestern University, and national CTSA partners. This role will also collaborate with NMH CRU leadership on operational and financial management of the CRU.

This position offers a unique opportunity to contribute to clinical trial innovation, implement best practices in clinical research administration, and support the translation of scientific discoveries into improved health outcomes. Candidates with expertise in clinical research management, project management, regulatory affairs, and financial oversight are strongly encouraged to apply.

This is a hybrid on-campus/remote position in order to best support the growing research enterprise at Northwestern University.

The NUCATS Institute is committed to maintaining a culture that values and prioritizes professional growth and work-life balance and to sustaining a diverse, inclusive, and welcoming environment for all team members.

Specific Responsibilities:

• Oversee and manage all operations within the Center for Clinical Research, including regulatory, finance, and staffing to support study start up, regulatory compliance, and participant management.

• Lead and collaborate with internal and external partners on best practices, knowledge sharing, professional development, and NUCATS initiatives. Serve as liaison to external CTSA professionals through collaborations and research initiatives.

• Collaborate with investigators, IRB, and other school and university units to support regulatory compliance, protocol needs, and internal and external regulators (e.g. FDA, IRB, ClinicalTrials.gov).

• Facilitate FDA IND/IDE regulatory needs by providing departments with appropriate resources and contacts to third party vendor.

• Manage financial aspects of appropriate clinical research projects, including budget negotiation, contract facilitation, billing and cost recovery, and monitoring financial performance. Align CCR finance and regulatory teams with school, university, and sponsor requirements.

• Manage projects and process improvement using metrics-based evaluation, including study start up times, participant recruitment and retention, by developing, implementing, and collaborating on standards of operations, quality improvement, and project management.

• Provide project management oversight for the Trial Innovation Network, CTSA collaboration sites, and other strategic initiatives within NUCATS, coordinating timelines, resources, projects, and stakeholder engagement for multicenter clinical trials and center-wide projects.

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• 5+ years of managerial experience in clinical trials.

• Demonstrated experience managing budgets, staffing, and operational planning across multiple service lines.

• Proven ability to multitask and prioritize deadlines in a highly matrixed environment.

• Strong background in regulatory affairs, including IRB compliance and human subjects research protections.

• Excellent communicator with strong interpersonal and leadership skills.

Growth-oriented mindset with the ability to manage multiple high-level initiatives simultaneously.

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

• Strong ability to collaborate across groups.
• Must work well in a team-oriented environment and collaborate closely with others.
• Well-organized with ability to handle multiple projects simultaneously.
• Ability to interact well with program participants: investigators, administrators, faculty, and research stakeholders.

Preferred Qualifications:

• ACRP or SoCRA certification required.

• Experience working with multisite clinical trials, including coordination, oversight, and regulatory alignment across institutions.

• Familiarity with FDA Investigational New Drug (IND)/Investigational Device Exemption (IDE) applications and related regulatory processes is preferred.

Target hiring range for this position will be between $78,482.00 to $98,102.00 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 Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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