Northwestern Medicine
Senior Regulatory Coordinator Stem Cell Transplant & Cell Therapy - Autoimmune D
Northwestern Medicine, Chicago, Illinois, United States, 60290
Overview
Senior Regulatory Coordinator
reflects the mission, vision, and values of NMHC, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
Under the direction of the Stem Cell Transplant and Cell Therapy - Autoimmune Diseases Program Manager, this position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Program. This role oversees the submission process to the Institutional Review Board (IRB) of new studies processed through the Program, with a focus on highly complex protocols involving more than minimal risk to research subjects. The submission process includes completion of extensive, detailed forms summarizing all aspects of a research study as well as the development of new research subject consent forms. This requires reading and interpreting highly specialized research protocols (involving stem cell transplant and cellular therapy products) and understanding federal regulations governing medical research. Acting on behalf of Principal Investigators, the Senior Regulatory Coordinator will address IRB concerns, questions and requests until approval is received. This position serves as the primary contact liaison between Principal Investigators, sponsor companies, and the IRB. It also manages the development of regulatory operating policies and procedures for the Clinical Research core and provides expertise to Investigators on regulatory policies, guidelines, compliance reporting, and submissions.
Responsibilities
Manages submission of all regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects. Works independently to complete high-acuity protocol reviews with little need for guidance from investigators and/or Research Team Members. May prepare submissions to NU Research Ancillary Departments, IND applications and renewals. Corresponds with the FDA throughout the IND process. Submits study renewal applications and study progress reports to the IRB.
Trains research staff regarding the process of submissions in eIRB. Provides guidance on form preparation and submission and informs Research staff of critical process and policy issues.
Interprets existing and/or new regulatory requirements, developments, and Institutional Regulatory Policies as they relate to human subject research to effectively communicate regulatory requirements to the research staff. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Recommends and implements regulatory process improvements.
Develops and manages the internal monitoring auditing program. Schedules, prepares and participates in all internal and external program audits (monitoring visits), interacts with regulatory agents, and Sponsor monitors. Ensures regulatory binders (including electronic regulatory binders) are well-maintained, organized and complete.
Communicates with IRB and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Monitors study closure activities and coordinates project close-out with study sponsors, investigators and the IRB.
Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.
Performs other duties as assigned.
Qualifications Required:
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.
Three years of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relevant experience required.
Preferred:
Master’s degree preferred.
Knowledge of or experience in NIH grant writing, applications, administration.
Experience working in oncology and/or familiarity with treatments like stem cell transplant and/or cellular therapies.
Equal Opportunity Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
If we offer you a job, we will perform a background check that includes a review of any criminal convictions. A conviction does not disqualify you from employment at Northwestern Medicine. We consider this on a case-by-case basis and follow all state and federal guidelines.
Benefits We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please review the Benefits section to learn more.
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reflects the mission, vision, and values of NMHC, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
Under the direction of the Stem Cell Transplant and Cell Therapy - Autoimmune Diseases Program Manager, this position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Program. This role oversees the submission process to the Institutional Review Board (IRB) of new studies processed through the Program, with a focus on highly complex protocols involving more than minimal risk to research subjects. The submission process includes completion of extensive, detailed forms summarizing all aspects of a research study as well as the development of new research subject consent forms. This requires reading and interpreting highly specialized research protocols (involving stem cell transplant and cellular therapy products) and understanding federal regulations governing medical research. Acting on behalf of Principal Investigators, the Senior Regulatory Coordinator will address IRB concerns, questions and requests until approval is received. This position serves as the primary contact liaison between Principal Investigators, sponsor companies, and the IRB. It also manages the development of regulatory operating policies and procedures for the Clinical Research core and provides expertise to Investigators on regulatory policies, guidelines, compliance reporting, and submissions.
Responsibilities
Manages submission of all regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects. Works independently to complete high-acuity protocol reviews with little need for guidance from investigators and/or Research Team Members. May prepare submissions to NU Research Ancillary Departments, IND applications and renewals. Corresponds with the FDA throughout the IND process. Submits study renewal applications and study progress reports to the IRB.
Trains research staff regarding the process of submissions in eIRB. Provides guidance on form preparation and submission and informs Research staff of critical process and policy issues.
Interprets existing and/or new regulatory requirements, developments, and Institutional Regulatory Policies as they relate to human subject research to effectively communicate regulatory requirements to the research staff. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Recommends and implements regulatory process improvements.
Develops and manages the internal monitoring auditing program. Schedules, prepares and participates in all internal and external program audits (monitoring visits), interacts with regulatory agents, and Sponsor monitors. Ensures regulatory binders (including electronic regulatory binders) are well-maintained, organized and complete.
Communicates with IRB and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Monitors study closure activities and coordinates project close-out with study sponsors, investigators and the IRB.
Tracks study approvals and expirations to ensure uninterrupted project approval. Maintains regulatory database and manages electronic filing of all regulatory documents.
Performs other duties as assigned.
Qualifications Required:
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.
Three years of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relevant experience required.
Preferred:
Master’s degree preferred.
Knowledge of or experience in NIH grant writing, applications, administration.
Experience working in oncology and/or familiarity with treatments like stem cell transplant and/or cellular therapies.
Equal Opportunity Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
If we offer you a job, we will perform a background check that includes a review of any criminal convictions. A conviction does not disqualify you from employment at Northwestern Medicine. We consider this on a case-by-case basis and follow all state and federal guidelines.
Benefits We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please review the Benefits section to learn more.
#J-18808-Ljbffr