Northwestern University
Job Description About Clinical Operations Manager
Department: MED-Clinical Trials Unit
Salary/Grade: EXS/8
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).
Specific Responsibilities:
Clinical Operations Manager
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.
- Other duties as assigned
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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 the 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 to develop & implement 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 the day-to-day activities of multiple teams. This position will manage administrative issues related to workload 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.
- Database form design and report development4.
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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 are met.
Supervision/Training Activities
- Trains direct and assign duties to clinical research coordinators and nursing staff. Assists in training of regulatory team and data assistants.
- Acts as a mentor in regard to the 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.
Minimum Qualifications:
Clinical Operations Manager
- 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.
Preferred Qualifications:
Clinical Operations Manager
- Experience working with the cardiovascular population
- Experience with REDCap or other database systems
Preferred Competencies: (Skills, knowledge, and abilities)
Clinical Operations Manager
- Enhanced clinical understanding of the cardiovascular population
- Familiarity with hospital electronic systems
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.
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 requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.
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.
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