Northwestern University
Regulatory Coord Sr FSM/CC
Northwestern University, Chicago, Illinois, United States, 60290
Department:
MED-Cancer CenterSalary/Grade:
EXS/7
Job Summary:Coordinates and guides the review and approval process of all research activities associated with complex clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare. These studies are considered complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance. Provides training and guidance to junior staff.Please describe clinical research studies: Cancer-relevant clinical and research studies involving human subjects.Specific Responsibilities:Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) some of which may be very complex in nature, recommending alternatives to ensure compliance and approval.Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU's IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance. Assists junior staff in resolving such issues and problems.Determines compliance required documentation and develops necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.Provides guidance and training to junior staff and research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.Serves as a resource to the clinical research office staff on regulatory concepts.Maintains the regulatory portion of the CRO database. This includes IRB approval dates, revision dates, protocol status, and adverse event tracking.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; 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.Minimum Competencies: (Skills, knowledge, and abilities.)Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines.Strong communication, writing, and interpersonal skills.Computer literacy in word processing, database use, and file management.Ability to work as part of a team.
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MED-Cancer CenterSalary/Grade:
EXS/7
Job Summary:Coordinates and guides the review and approval process of all research activities associated with complex clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare. These studies are considered complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets. Interprets and applies rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance. Provides training and guidance to junior staff.Please describe clinical research studies: Cancer-relevant clinical and research studies involving human subjects.Specific Responsibilities:Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) some of which may be very complex in nature, recommending alternatives to ensure compliance and approval.Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU's IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance. Assists junior staff in resolving such issues and problems.Determines compliance required documentation and develops necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.Provides guidance and training to junior staff and research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.Serves as a resource to the clinical research office staff on regulatory concepts.Maintains the regulatory portion of the CRO database. This includes IRB approval dates, revision dates, protocol status, and adverse event tracking.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; 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.Minimum Competencies: (Skills, knowledge, and abilities.)Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines.Strong communication, writing, and interpersonal skills.Computer literacy in word processing, database use, and file management.Ability to work as part of a team.
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