Clinical Operations Manager

Department: MED-Clinical Trials Unit
Salary/Grade: EXS/8

Target hiring range for this position will be between $70,017 - $87,522 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.

Job Summary:

Manages all activities associated with highly complex clinical research studies. 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, clinical research organizations, and pharmaceutical partners. 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).

• On site activity required 3-5 days per weeks - varies by clinical need

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 partners.
• Directs actions to ensure high quality clinical research standards are maintained across all partner programs.

• Recruit, hire, train, and supervise clinical research staff across partner programs.

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 nursing staff and Principal Investigator (PI).
• Manages day to day activities of clinical research teams and oversees interaction with critical clinical partners such as pharmacy, nursing, pathology core, etc.
• Ensures that the conduct of 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.
• Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
• Leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
• Reviews scientific literature & evaluates & recommends applicable techniques & procedures.

• Works on the development of standard operating procedures for clinical 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 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.
• Ensures the clinical functioning of the office is efficient by providing supervision of day to day activities of multiple teams. This position will manage administrative issues related to work load for the staff, including activities such as tracking current and expected workloads and assigning new protocols to coordinators. Assists with internal audits of research charts 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 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

• Ensures appropriate allocation & compliance of study budget.
• Invoices study sponsors for study tests/procedures.
• Coordinates & participates in budgetary negotiations with industry sponsors.
• Oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.

Supervision/Training Activities

• Trains, directs, and assigns duties to clinical research coordinators and nursing staff. Assists in training of regulatory team and data assistants.
• Acts as a mentor in regard to education of junior coordinators.
• Monitor 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 trials 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 NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

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

• Action oriented - Willing or likely to take practical action to deal with a problem or situation.
• Coachability - Receptive to feedback, willing to learn, embracing continuous improvement.
• Collaboration - Facilitates open and effective communication, cooperation and teamwork within and outside of one's own team.
• Collegiality - Helpful, respectful, approachable; builds strong working relationships and a positive work environment

Preferred Qualifications: (Education and experience)

• Experience working with the cardiovascular population
• Experience with IRB submissions
• Experience with REDCap or other database system

Preferred Competencies: (Skills, knowledge, and abilities)

• Enhanced clinical understanding of the cardiovascular population
• Familiarity with hospital electronic systems
• Familiarity with research budgeting and billing

Benefits:

At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, 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.