Clinical Operations Manager
Apply NowCompany: Northwestern University
Location: Chicago, IL 60629
Description:
Department: MED-Mesulam Ctr Cog Neur & Alz
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 research program and mission. 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 logistical and financial feasibility and ensures completion of contract requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department to ensure proper conduct of human subjects research. This position will additionally provide statistical and data reporting expertise for a variety of projects within department, including data management, analysis, and summarizing/communicating results across multiple projects and disciplines. May additionally co-author scientific papers for presentation & publication & as well as assist with writing, submission & administration of grants.
The Mesulam Center for Cognitive Neurology and Alzheimer's Disease is a multi-departmental component of the Feinberg School of Medicine. We specialize in the clinical care and scientific study of neurological diseases that interfere with cognition and behavior. Areas of emphasis include age-related memory impairments and dementias. Our three interacting missions are to investigate the causes and clinical characteristics of neurodegenerative diseases, to ensure that our patients are the beneficiaries of the latest advances, and to explore the neural foundations of behavior and cognition in health and disease.
This position will serve as the Manager for the Clinical Trials Unit, directed by Dr. Ian Grant, and housed within the Mesulam Center for Cognitive Neurology and Alzheimer's Disease. The Clinical Trials Unit currently works on several interventional and observational studies with subjects that have subjective complaints of memory loss, Mild Cognitive Impairment (MCI), Early Onset Alzheimer's Disease (EOAD), mild to moderate Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), and semantic variant Primary Progressive Aphasia (svPPA).
This position will work directly with Dr. Grant to provide management and oversight for all components of the Clinical Trials Unit to ensure all milestones and goals are met. This position will ensure completion of contract /sub-contract and sIRB requirements. It will also include oversight of clinical operations and logistics. The manager will collaborate with the department leadership 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.
Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
Specific Responsibilities :
Program Development
Performs other duties as assigned.
Minimum Qualifications:
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, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.
#LI-ER1
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 research program and mission. 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 logistical and financial feasibility and ensures completion of contract requirements & client specifications. Will develop policies, SOPs and training programs for research staff throughout the department to ensure proper conduct of human subjects research. This position will additionally provide statistical and data reporting expertise for a variety of projects within department, including data management, analysis, and summarizing/communicating results across multiple projects and disciplines. May additionally co-author scientific papers for presentation & publication & as well as assist with writing, submission & administration of grants.
The Mesulam Center for Cognitive Neurology and Alzheimer's Disease is a multi-departmental component of the Feinberg School of Medicine. We specialize in the clinical care and scientific study of neurological diseases that interfere with cognition and behavior. Areas of emphasis include age-related memory impairments and dementias. Our three interacting missions are to investigate the causes and clinical characteristics of neurodegenerative diseases, to ensure that our patients are the beneficiaries of the latest advances, and to explore the neural foundations of behavior and cognition in health and disease.
This position will serve as the Manager for the Clinical Trials Unit, directed by Dr. Ian Grant, and housed within the Mesulam Center for Cognitive Neurology and Alzheimer's Disease. The Clinical Trials Unit currently works on several interventional and observational studies with subjects that have subjective complaints of memory loss, Mild Cognitive Impairment (MCI), Early Onset Alzheimer's Disease (EOAD), mild to moderate Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), and semantic variant Primary Progressive Aphasia (svPPA).
This position will work directly with Dr. Grant to provide management and oversight for all components of the Clinical Trials Unit to ensure all milestones and goals are met. This position will ensure completion of contract /sub-contract and sIRB requirements. It will also include oversight of clinical operations and logistics. The manager will collaborate with the department leadership 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.
Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.
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 all department divisions.
- Recruit, hire, train, and supervise junior clinical research staff.
- 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, radiologic technologists, nursing staff, etc.
- 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 clincical research staff and also monitors compliance with procedures.
- 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.
- 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.
- Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.
- Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.
- 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.
- Analyzes, evaluates & interprets data to determine relevance to research
- Monitors data use and storage to ensure compliance with current local, state, & federal regulatory guidelines, requirements, laws
- Develops queries to access study-relevant clinical data from the EDW system as a power user, in compliance with FSM policies
- 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.
- Assists with the management of research study budgets, which may include deciding on & approving expenditures of funds based on budget
- 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.
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 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.
- 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, Access, Outlook)
- Master's degree in public health, biostatistics or statistics; or equivalent level of education or experience.
- Knowledge of medical/institutional research procedures
- Prior experience in managing human subject's research
- Prior experience working with and passion for the older adult population
- Prior experience with REDCap of similar database
- Experience with SQL or similar
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, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.
#LI-ER1