Northwestern University Chicago , IL 60602
Posted 3 weeks ago
Department: MED-Cancer Center
Salary/Grade: EXS/9
Job Summary:
Clinical Focus:
This position provides clinical operational management oversight for multiple operations managers of the Cancer Center Clinical Trials Office (CTO). Manages all activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Responsible for management, administration, organization and conduct of the clinical trials operations. Oversees day-to-day operations including assigning and supervising study staff to disease teams, identifying & securing needed resources, identifying the need for process improvement and developing and implementing plans. Provides leadership, training, coaching and mentoring of clinical operation supervisors and staff. Works collaboratively with operational leaders of the CC Finance, IT and other Medical School and Hospital units and departments engaged in clinical research.
Regulatory Focus:
Defines and implements regulatory strategies and priorities in conjunction with Director of Research Integrity and Compliance. Ensures application of established policies and best practice regulatory standards across network regions for all filings, maintenance of existing trial registrations and agency interactions.
May serve as primary regulatory contact with for FDA inspections. Assists Regulatory staff by outlining regulatory strategy and providing data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical &/or social-behavioral research studies including Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials.
Organizes, plans, and controls work flow of the regulatory staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff.
QA Focus:
Responsible for managing the Data Quality Assurance department to provide strategy for the oversight and quality services for oncology network trial management, CTMS electronic systems, data integrity processes, and related continuous process improvement initiatives. Provides strategic leadership in driving a consistent compliance and validation approach to policies, procedures, and standards. Performs Electronic Records / Electronic Signatures regulation and related regulation surveillance to provide guidance and instruction to the Cancer Center to ensure compliance with regulatory requirements.
Anticipates and develops QA activities and processes related to electronic systems oversight based on risk. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
Organizes, plans, and controls work flow of the QA staff within the assigned teams and is responsible for ensuring clinical trials are conducted in compliance with federal, state and institutional guidelines. This position will provide significant input into the development of SOPs and training programs for clinical staff.
May co-author scientific papers for presentation & publication & coordinates writing, submission & administration of grants. 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).
Works extensively to create and nurture collaborations and partnerships with outside affiliate institutions, nationally recognized clinical research organizations, and pharmaceutical partners.
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:
Technical
Administrative
Data
Finance
Supervision/Training Activities
Program Development
Miscellaneous
Performs other duties as assigned.
Minimum Qualifications:
Minimum Competencies: (Skills, knowledge, and abilities.)
Preferred Qualifications:
Target hiring range for this position will be between $76,196 - $107,151 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 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.
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