Research Manager Ophthalmology

Job Summary:

Oversees the Department of Ophthalmology Clinical research program in regulatory compliance matters; provides direction and thought leadership to develop strategic administrative initiatives that meet the research mission of the department. Guides the effective, compliant, & efficient daily management of all operational, financial, & business functions in support of the research program & in coordination with central offices such as Sponsored Project and Research Catalysts (SPARC) and Northwestern University Clinical and Translational Sciences Institute (NUCATS). Represents the research program on internal & external business affairs & is viewed as an expert resource regarding the research program administrative affairs. Leads the clinical research coordinator team and manages a variety of tasks related to regulatory compliance, collaboration studies and study startup.

The research program is summarized below. (Definitions: Program: plan or system of taking action toward a goal. Project: planned actions with specified beginning & end.)

The Clinical Science research programs are a combination of clinical, federal, and faculty-initiated studies.

Most active members of these studies include: faculty members, fellows, residents, medical student and inter-departmental partners (SPARC/NUCATS).

• Administration
• Budget & Financial
• Communications
• Evaluation
• Events
• Facilities & Safety
• PI/Faculty Support
• Grants/Contracts
• Human Resources
• IT Services
• Outreach
• Program Development
• Recruitment
• Regulatory Compliance
• Strategic Planning
• Student Support

Specific Responsibilities:

Administration

• Directs and leads development of programs/projects strategic plan.
• Oversees & ensures that day-to-day operations are appropriately managed,
• efficient and effective.
• Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and
• internal/external regulatory and oversight groups (NU's IRB, sponsors (NIH,
• industry), government agencies (FDA), etc.) to resolve issues and problems,
• negotiate compromises, and offer alternatives and recommendations to facilitate
• and expedite research while ensuring compliance.
• Oversees data analysis & recommends & implements changes & improvement to better ensure attainment of research studies.
• Oversees documentation of agreements between NU and partner institutions, ensuring that agreements are complete and reviewed by all necessary NU officials.
• Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare.
• Guides and coordinates all associated submission, documentation, and reporting
• processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) some of which may be very complex in nature, recommending alternatives to ensure compliance and approval.
• Manages customer service; creates associated practices & procedures & metrics
• to measure success.
• Operationalizes goals & objectives; ensures that resources are created or
• obtained.

Budgets & Financial

• Ensures that the program/project meets associated revenue & expense goals.
• Develops and implements ideas for improving business processes and increasing program/project revenues and margins.
• Plans & manages complex budget(s) which fund strategic mission including financial sustainability & enhancement models.
• Plans & implements annual budget process.
• Oversees all daily, monthly & annual financial activities including transactions, analysis, & reporting.
• Approves funds reallocation within budget as necessary & appropriate.
• Communication, Outreach & Recruitment
• Directs program/project marketing/branding efforts.
• Identifies and implements short- and long-term strategies and plans to meet program/project goals.
• Engages in outreach/field relations serving a number of goals, including recruitment, participation, sponsorship, relationship building, etc. to support continued program/project development & improvement.
• Interacts with internal/external resources & organizations to identify new markets & opportunities.
• Actively obtains market intelligence by monitoring program/project peers/competitors and sharing information with appropriate groups.
• Builds relationships with appropriate communities & organizations that will result.

Evaluation

• Oversees development & implementation of evaluation processes, quantitative & qualitative measurements that ensure that program/project benchmarks are successfully attained and communicated in a timely and efficient manner.
• Manages evaluation processes; recommends & implements changes for enhancement; monitors effectiveness through follow-up evaluation studies.
• Collaborates with internal/external resources to develop meaningful outcome measurements and methods of program/project evaluation that will lead to enhancement.

Events

• Develops a comprehensive program of events such as lectures, symposia, speaker series, workshops, conferences, cultural events etc. in collaboration with internal & external resources.
• Develops proposals & recruits faculty leaders for interdisciplinary research working groups, and works with them to develop programming

Faculty Support

• Oversees recruitment of faculty
• Provides strategic recommendation for management of faculty appointments, credentialing & exit (retirement & termination) processes.
• Reviews policies, recommends changes, implements new & ensures consistent interpretation.
• Oversees all aspects of faculty administrative tasks (colloquium, seminar, travel, faculty COI survey, annual report, etc.) ensuring optimal faculty support.

Grants & Contracts

• Manages professional research administration support staff in order to facilitate & enhance all administrative grant processes & related compliance.
• Responsible for pre- & post-award administration completed by research administrators.
• Builds relationships with Principal Investigators (PIs) & NU research associated offices
• Transfers knowledge & advises on research policy & procedure.
• Manages payroll administration for research appointments.

Human Resources

• Determines & implements organizational structures to align with strategic mission.
• Manages implementation of human resource programs, policies, procedures & talent management lifecycle & related mentoring & training.
• Oversees recruitment & selection process; Performance Excellence plan for each employee; & merit increase process.
• Manages & provides consultation regarding complex performance problems & issues; administers leaves; approves timesheets & oversees completion of annual staff Conflict of Interest survey.
• Interprets HR policy to maximize effectiveness of HR administration to meet strategic plan objectives.

Program Development

• Manages goals, objectives, outcome measurements and metrics, financial feasibility, marketing strategies and collaboration opportunities with other internal and external organizations.
• Manages the ongoing development and refinement of the program's/project's current and future curriculum and course offerings in consultation with subject matter experts.
• Manages the recruits, hires, and directs instructors/faculty.
• Provides leadership for planning, scheduling, delivering and maintaining program(s)/project(s) to sustain quality instruction in all educational activity.
• Manages for consistently high quality standards across all partner programs/projects, including admissions, teaching, grading, service levels, and facilities.

Regulatory Compliance

• Oversees development & implementation of processes & procedures for all safety, security & compliance programs.
• Ensures compliance with all applicable federal, state, local & NU laws, regulations, policies & procedures.
• Oversees creation &/or implementation of associated training.

Strategic Planning

• Creates & leads a coordinated program of activities designed to increase program/project objectives.
• Develops & executes strategies to involve internal/external constituents and cultivate new individual, corporate, institutional &/or foundation collaborations.

Student Support

• Oversees recruitment, application evaluation, interview, selection and notification of students or participants.
• Establishes admissions criteria in accordance with associated NU policy.
• Manages student orientation, registration, student life, graduation, etc.
• Oversees all aspects of faculty administrative tasks (colloquium, seminar, travel, faculty COI survey, annual report, ) ensuring optimal faculty support.

Supervision

• 1 Supervises 1-2 staff.

Miscellaneous

Performs other duties as assigned.

Minimum Qualifications:

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience.
• 4 years program/project administration or other relevant experience.

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

• Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
• Attention to Detail Consistently displays accuracy and attention to detail
• Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
• Ability to manage & lead a team

Preferred Qualifications:

• CITI certification
• Two years of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols

Target hiring range for this position will be between $63,079-$78,849 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

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