Northwestern University
Clinical Research Operations Lead FSM/CC
Northwestern University, Chicago, Illinois, United States, 60290
Job ID:
52523 Location:
Chicago, Illinois Department:
MED-Cancer Center Salary/Grade:
EXS/9 Job Summary: 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 and/or social-behavioral research studies considered very complex by factors such as multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions, and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Responsible for the 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 and 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 the 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 for FDA inspections. Outlines regulatory strategy and provides data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical and/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 ensures clinical trials are conducted in compliance with federal, state and institutional guidelines. Provides input into SOPs and training programs for clinical staff. Quality Assurance Focus: Manages 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 surveillance to guide compliance with regulatory requirements. Develops QA activities related to electronic systems oversight based on risk and mentors QA representatives on project teams. Ensures clinical trials are conducted in compliance with applicable guidelines and SOPs. Specific Responsibilities: Technical: Provide leadership support for clinical trials; manage and coordinate clinical study design and implementation at program and functional levels according to GCP and SOPs; lead teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits; oversee operational input and oversight in designing, planning, initiating and completing trials; review protocols and related documents; oversee patient billing processes; review scientific literature; collaborate with CRO Quality Control on SOP development; lead cross-functional teams in strategy and issue resolution. Administrative: Act as liaison between sponsoring agencies and collaborating organizations; oversee recruitment and management of clinical research staff and training; support inspection readiness; develop processes and protocols to support studies; maintain up-to-date study documents per regulatory guidelines. Data: Manage project data including processing, accuracy, analysis and reporting; collaborate with project and IT staff to prepare reports; provide data management and analysis consultation. Finance: Ensure appropriate allocation and compliance; manage study budgets and timelines; coordinate negotiations with industry sponsors. Supervision/Training: Train and supervise clinical research staff; mentor junior coordinators; provide regulatory training; supervise sponsor/monitor interactions and prep meetings; oversee day-to-day activities of multiple teams and staff, including interviewing and hiring; assist with audits and workload planning. Program Development: Assist in setting goals and metrics; work with Cancer Center leadership to implement policies and training across partner sites; recruit, hire, train, and supervise staff across partner programs. Miscellaneous: Perform other duties as assigned. Minimum Qualifications: Bachelor’s degree in a health/science field or related; or equivalent combination of education and experience with 5 years of research-related experience. Master’s degree or higher in a related field or equivalent with 3 years of research experience. Supervisory or project management experience required. Must complete NU’s IRB CITI training before interacting with participants and re-certify every 3 years. Clinical Research Coordinator Certification; if not currently obtained, required within 9 months of hire. Minimum Competencies: Excellent written and oral communication skills Strong organization and interpersonal skills Computer literacy in Microsoft Office, Internet and database use Preferred Qualifications: Nursing degree, master’s or other graduate degree or equivalent experience Past experience in hematology/oncology clinical trials Past experience with clinical trial budgets Benefits and Work-Life: Benefits include health care plans, retirement options, tuition discounts, and more. For details visit: https://www.northwestern.edu/hr/benefits/index.html Work-Life programs and flexible work arrangements are available where possible. Details: https://www.northwestern.edu/hr/benefits/work-life/index.html Professional Growth & Development resources are available. Details: https://www.northwestern.edu/hr/learning/index.html Equal Opportunity:
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. For accommodations in the application process, contact the Office of Civil Rights and Title IX Compliance.
#J-18808-Ljbffr
52523 Location:
Chicago, Illinois Department:
MED-Cancer Center Salary/Grade:
EXS/9 Job Summary: 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 and/or social-behavioral research studies considered very complex by factors such as multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions, and/or multi-million dollar budgets. Ensures completion of contract requirements and client specifications. Responsible for the 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 and 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 the 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 for FDA inspections. Outlines regulatory strategy and provides data needed to support filings, responses to Health Authorities inquiries, and trial registration maintenance. Oversees the regulatory workforce activities associated with highly complex biomedical and/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 ensures clinical trials are conducted in compliance with federal, state and institutional guidelines. Provides input into SOPs and training programs for clinical staff. Quality Assurance Focus: Manages 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 surveillance to guide compliance with regulatory requirements. Develops QA activities related to electronic systems oversight based on risk and mentors QA representatives on project teams. Ensures clinical trials are conducted in compliance with applicable guidelines and SOPs. Specific Responsibilities: Technical: Provide leadership support for clinical trials; manage and coordinate clinical study design and implementation at program and functional levels according to GCP and SOPs; lead teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits; oversee operational input and oversight in designing, planning, initiating and completing trials; review protocols and related documents; oversee patient billing processes; review scientific literature; collaborate with CRO Quality Control on SOP development; lead cross-functional teams in strategy and issue resolution. Administrative: Act as liaison between sponsoring agencies and collaborating organizations; oversee recruitment and management of clinical research staff and training; support inspection readiness; develop processes and protocols to support studies; maintain up-to-date study documents per regulatory guidelines. Data: Manage project data including processing, accuracy, analysis and reporting; collaborate with project and IT staff to prepare reports; provide data management and analysis consultation. Finance: Ensure appropriate allocation and compliance; manage study budgets and timelines; coordinate negotiations with industry sponsors. Supervision/Training: Train and supervise clinical research staff; mentor junior coordinators; provide regulatory training; supervise sponsor/monitor interactions and prep meetings; oversee day-to-day activities of multiple teams and staff, including interviewing and hiring; assist with audits and workload planning. Program Development: Assist in setting goals and metrics; work with Cancer Center leadership to implement policies and training across partner sites; recruit, hire, train, and supervise staff across partner programs. Miscellaneous: Perform other duties as assigned. Minimum Qualifications: Bachelor’s degree in a health/science field or related; or equivalent combination of education and experience with 5 years of research-related experience. Master’s degree or higher in a related field or equivalent with 3 years of research experience. Supervisory or project management experience required. Must complete NU’s IRB CITI training before interacting with participants and re-certify every 3 years. Clinical Research Coordinator Certification; if not currently obtained, required within 9 months of hire. Minimum Competencies: Excellent written and oral communication skills Strong organization and interpersonal skills Computer literacy in Microsoft Office, Internet and database use Preferred Qualifications: Nursing degree, master’s or other graduate degree or equivalent experience Past experience in hematology/oncology clinical trials Past experience with clinical trial budgets Benefits and Work-Life: Benefits include health care plans, retirement options, tuition discounts, and more. For details visit: https://www.northwestern.edu/hr/benefits/index.html Work-Life programs and flexible work arrangements are available where possible. Details: https://www.northwestern.edu/hr/benefits/work-life/index.html Professional Growth & Development resources are available. Details: https://www.northwestern.edu/hr/learning/index.html Equal Opportunity:
Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. For accommodations in the application process, contact the Office of Civil Rights and Title IX Compliance.
#J-18808-Ljbffr