Regulatory Coordinator Sr

We need to output HTML fragment with sections: About the role? The posting includes Job Summary, Specific Responsibilities, Minimum Qualifications, Minimum Competencies, Preferred Qualifications, Preferred Competencies, Benefits, Work-Life And Wellness, Professional Growth & Development. Also Salary/Grade and Target hiring range. So we need sections: About the role (maybe Job Summary), Responsibilities (Specific Responsibilities), Requirements (Minimum Qualifications + Minimum Competencies?), Qualifications (Preferred Qualifications + Preferred Competencies?), Benefits, maybe Work-Life And Wellness and Professional Growth & Development could be part of Benefits or separate sections? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include sections: About the role (Job Summary), Responsibilities (Specific Responsibilities), Requirements (Minimum Qualifications and Minimum Competencies), Qualifications (Preferred Qualifications and Preferred Competencies), Benefits (Benefits, Work-Life And Wellness, Professional Growth & Development maybe combined). Pay: we have salary range $70,000 - $85,000. So include Pay section. Schedule: not mentioned, so omit. We must not repeat job title as heading. No Job ID. Remove boilerplate: EEO, accommodations, etc. Also remove navigation, cookie, legal. Also remove duplicated lines. We must preserve all substantive information. So include salary range and note that offer determined by education etc. Should we include that sentence? Yes, it's substantive. So in Pay section we can include that sentence. We need to use

• for any list of duties/requirements/benefits. For prose use

  . For sections like Requirements we have both education/experience and competencies; we can list them as

  . Similarly Qualifications: preferred qualifications and competencies. Benefits: list items. Work-Life And Wellness and Professional Growth & Development could be included as subpoints under Benefits? But they are separate sections maybe. However instruction: prefer a few substantive sections over many thin ones. Could combine them into Benefits section as subpoints. But they are distinct topics; still could be under Benefits as list items. However they are not benefits per se but programs. Might be okay to include them as separate sections if they have content. But to keep few sections, we can include them under Benefits as list items. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Benefits, Pay. Now craft HTML. About the role: use

  with Job Summary text. Responsibilities:

  • each bullet from Specific Responsibilities. Requirements: combine Minimum Qualifications (education/experience) and Minimum Competencies (skills). Could split into two sublists? But we can just list all items as
  • . Might be long but okay. Qualifications: Preferred Qualifications and Preferred Competencies. Benefits: list benefits items from Benefits paragraph plus Work-Life And Wellness and Professional Growth & Development items. Pay: include salary range and note about determination. Make sure not to include filler like "commensurate with experience". Not present. Now extract text. Job Summary: "Under the direction of the Comprehensive Transplant Center’s Director of Clinical Research and the Administrative Director, the position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Clinical Research core. 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." We need to keep punctuation. Might need to fix spacing: there is missing space after periods. We'll keep as is but could add spaces for readability but not required. We'll preserve original. Specific Responsibilities list: - 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. - Miscellaneous Performs other duties as assigned. Note "Miscellaneous Performs other duties as assigned." could be a bullet. 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 year's of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relavant experience required." Minimum Competencies: list: RER - Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines. COW - Strong communication, writing, and interpersonal skills. COMP - Computer literacy in word processing, database use, and file management. TEAM PLA - Ability to work as part of a team. Preferred Qualifications: "Master's degree preferred; One year or more of experience managing staff;" Preferred Competencies: "Previous interaction with IRB. One year of work experience in a regulatory and or medical research environment having developed a strong working knowledge of clinical research protocols." Benefits paragraph: "At Northwestern, we are proud to provide meaningful and competitive benefits. The available benefits package for this position will include health, dental, vision, disability, and life insurance; paid vacation and holidays; paid medical/sick and parental leave; tuition benefits for the employee and dependents; pre-tax and flex spending accounts for commuting and dependent care; generous retirement savings options; and wellness programs. For a comprehensive overview of available benefits, including eligibility details, 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." Pay: "Department: MED-Transplant Center Salary/Grade: EXS/7 Target hiring range for this position will be between $70,000 - $85,000. 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." We need to exclude Department line? It's metadata but could be included in Pay section? The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

    or drop it. Department is minor metadata; we could include in a short p before Pay section or incorporate into Pay paragraph. Probably include in Pay section as part of text. Now construct HTML. We'll output:

    About the role

    Under the direction of the Comprehensive Transplant Center’s Director of Clinical Research and the Administrative Director, the position will be responsible for all regulatory matters concerning the protection of human subjects for studies conducted in the Clinical Research core. 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.

    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.
    • Performs other duties as assigned.

    Requirements

    • 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.
    • 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.