Clinical Operations Manager

Department: MED-Dermatology
Salary/Grade: EXS/8

Job Summary:

Manages all activities associated with complex clinical research studies and provides leadership and advanced problem solving in support of the department's human subjects research regulatory operations and quality assurance. 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.

Creates and nurtures collaborations and partnerships with outside affiliate institutions, research sponsors, and various departments within the institution. 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).

Responsible for review of studies for regulatory feasibility and ensure completion of regulatory requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department of Dermatology to ensure proper conduct and submission of human subject's research.

This position supports the mission, vision and strategic plan of the Department of Dermatology. The manager will collaborate with the Director of the Dermatology Clinical Trials Unit to ensure exceptional clinical research support and a high level of professionalism and quality customer service. The Manager focuses others on a clearly defined, clearly communicated vision and engages individuals and groups to achieve that vision. The Manager identifies and develops organizational talent and embraces continuous learning of self and others.

This is a one-year term position, with the opportunity for renewal based on funding availability and performance.

Specific Responsibilities:

Program Development

• Assists with determining goals, objectives, outcome measurements and metrics, financial feasibility, and collaboration opportunities as it relates to clinical research with other internal and external organizations. Implements policies, procedures, and training for clinical research within the department.
• Directs actions to ensure high quality clinical research standards are maintained across entire unit.
• Recruit, hire, train, and supervise junior clinical research regulatory staff.

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.
• 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 local clinical staff and Principal Investigator (PI).
• Manages day-to-day activities of clinical research team and oversees interaction with critical clinical partners such as physicians, pharmacists, and research technicians.
• Ensures that the conduct of study protocols is 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 the study or study sponsors.
• Leads research staff in preparing for internal, NU IRB, Sponsor, and/or FDA audits.
• Develops and maintains standard operating procedures for clinical research staff and also monitors compliance with procedures.

Administrative

• Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
• Oversees recruitment and management of clinical research regulatory staff.
• Completes applications and obtains appropriate approvals from various groups for all necessary study start-up functions.
• Plans, develops & implements new processes, policies, and protocols to support research studies & maximize/extend study capabilities.
• Provides supervision of day-to-day research activites and manges administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators and assistants. Assists with internal audits of research charts and data to ensure compliance with protocol requirements.
• 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 creation and management of databases, monitoring for data accuracy, and evaluation and analysis of data ensuring that results meet project information and deliverable objectives.
• Monitors data use and storage to ensure compliance with current local, state, & federal regulatory guidelines, requirements, laws

Finance

• Assists with the management of research study budgets, which may include deciding on & approving expenditures of funds based on budget

Supervision/Training Activities

• Trains, directs, and assigns duties to clinical research and regulatory staff.
• Acts as a mentor in regard to education of junior coordinators.
• Monitor institutional and 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 research staff, evaluating opportunities to improve productivity and operational efficiency.

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 7 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 5 years' research study or other relevant experience.
• Supervisory or project management experience required.
• Must complete Northwestern's IRB CITI training before interacting with any participants & must re-certify every 3 years.
• Certification in clinical research (i.e. CCRC or CCRP) through ACRP or SOCRA
• Clearance by NMHC Access Program

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

• Excellent written and oral communication skills.
• Strong organization and interpersonal skills.
• Attention to detail / ability to work flexibly across multiple projects at a time.
• Microsoft Office (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications: (Education and experience)

• Master's degree in public health, biostatistics or statistics; or equivalent level of education or experience.

Preferred Competencies: (Skills, knowledge, and abilities)

• Knowledge of medical/institutional research procedures
• Proficiency in REDCap

Target hiring range for this position will be between $83,000-$93,000 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 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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