What are the responsibilities and job description for the Research Compliance Analyst I/II/III position at Auburn?

Position Details

Position Information

Requisition Number

S4217P

Home Org Name

Office of Research Compliance

Division Name

VP for Research and Economic Dev

Position Title

Research Compliance Analyst I / II / III

Job Class Code

KC15

Appointment Status

Full-time

Part-time FTE

Limited Term

Limited Term Length

Job Summary

This is a pool posting for future vacancies in this job classification.

Auburn University's Office of the Sr. Vice President for Research and Economic Development is actively recruiting applicants for the position of Research Compliance Analyst I / II / III . This position will be responsible for the evaluation, analysis, and administrative support for one or more compliance programs and / or processes assigned to the Office of Research Integrity and Compliance. This includes the Research Integrity Program, the Animal Care and Use Program, the Human Research Protection Program, and the Biological Safety Program and their corresponding compliance committees. Facilitates institutional responsibilities for and oversight of compliance with federal regulatory requirements, state laws, and institutional policies and procedures.

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Essential Functions

Level I

Assists with regulatory advice, consultation, and support for investigators, compliance committees to include Institutional Review Boards for the Protection of Human Subjects in Research ( IRB ), Institutional Animal Care & Use Committee ( IACUC ), and Institutional Biosafety Committee ( IBC ), and university or college research administration on matters related to research integrity and / or compliance. Remains current on applicable federal regulations, state laws, and institutional policies related to areas of assignment.
Assists in providing recommendations and assists with development, implementation, and delivery of education and training programs to ensure compliance with federal regulations, state laws, and institutional policies.
Assists in conducting regulatory review and assessment of protocols, applications, and Conflict of Interest ( COI ) disclosures to evaluate adherence to applicable regulations, laws, policies, and guidance. In collaboration with the research integrity and compliance leadership team, determines needed changes, steps, actions necessary to achieve compliance.
Assists in developing and supporting public relations and communication efforts for internal research integrity and / or compliance stakeholders and external agencies. Disseminates program outcomes and information through publications, articles, notices, or other media and updates the Office of Research Integrity and Compliance's website on a timely basis.
May participate in monitoring and inspection activities and evaluations of reported concerns to support institutional responsibilities for compliance oversight and the ethical and responsible conduct of research and regulated activities.
Assists with development, review, and maintenance of policies, procedures, tools and resources based on changing regulatory environment or risk-based program analysis.
Assists with, researches, and gathers background information on a variety of research compliance and regulatory topics. Compiles information, prepares reports, and records communications of a confidential nature for the purpose of documenting regulatory compliance. Creates and runs queries and analyses on research compliance-related data.
Acts as a liaison between faculty, students, staff, and the Office of Research Compliance. May assist researchers in preparing submissions, responding to reviewer comments, and technical assistance throughout the process lifecycle.
Assists in evaluating and implementing the process of improvements that align with the University's strategic plan to streamline processes, eliminate outdated programs, and create efficiencies.
Assists with other related duties as assigned including providing backup support within the unit and across the research integrity and / or compliance programs.

Level II

Provides policy and procedural advice, consultation, and support to investigators, compliance committees such as Institutional Review Boards for the Protection of Human Subjects in Research ( IRB ), Institutional Animal Care & Use Committee ( IACUC ), and Institutional Biosafety Committee ( IBC ), and university or college research administration on matters related to research integrity and / or compliance. Remains current on applicable federal regulations, state laws, and institutional policies related to areas of assignment.

Provides recommendations and assists with development, implementation, and delivery of education and training activities to ensure compliance with federal regulations, state laws, and institutional policies.

Conducts administrative review and assessment of protocols, applications, and Conflict of Interest ( COI ) disclosures based on established guidance. In collaboration with the research integrity and compliance leadership team, determines needed changes, steps, actions necessary to achieve compliance.

Develops and supports public relations and communication efforts for internal research integrity and / or compliance stakeholders. Disseminates program outcomes and information through publications, articles, notices, or other media.

Assists with monitoring and inspection activities to support institutional responsibilities for compliance oversight and the ethical and responsible conduct of research and regulated activities.

Assists with development, review, and maintenance of procedures, tools and resources based on changing regulatory environment.

Researches and gathers background information on a variety of research compliance and regulatory topics. Compiles information and prepares reports, records, and communication of a confidential nature for the purpose of documenting regulatory compliance.

Assists researchers in preparing submissions, responding to reviewer comments, and providing technical assistance throughout the process lifecycle.

Evaluates, recommends, and assists with implementation of process improvements that align with the University's strategic plan to streamline processes, eliminate outdated programs, and creating efficiencies.

Performs other related duties as assigned including providing backup support within unit and across the research integrity and / or compliance programs.

Level III

Provides regulatory advice, consultation, and support to investigators, compliance committees to include Institutional Review Boards for the Protection of Human Subjects in Research ( IRB ), Institutional Animal Care & Use Committee ( IACUC ), and Institutional Biosafety Committee ( IBC ), and university or college research administration on matters related to research integrity and / or compliance. Remains current on applicable federal regulations, state laws, and institutional policies related to areas of assignment.

Leads development, implementation, and delivery of comprehensive education and training programs to ensure compliance with federal regulations, state laws, and institutional policies.

Conducts regulatory review and assessment of protocols, applications, and Conflict of Interest ( COI ) disclosures to evaluate adherence to applicable regulations, laws, policies, and guidance. In collaboration with the research integrity and compliance leadership team, determines needed changes, steps, and actions necessary to achieve compliance.

Develops and supports public relations and communication efforts for internal research integrity and / or compliance stakeholders and external agencies. Disseminates program outcomes and information through publications, articles, notices, or other media.

Participates in monitoring and inspection activities and evaluations of reported concerns to support institutional responsibilities for compliance oversight and the ethical and responsible conduct of research and regulated activities.

Assists with development, review, and maintenance of policies, procedures, tools, and resources based on changing regulatory environment or risk-based program analysis.

Acts as a liaison between faculty, students, or staff and the Office of Research Integrity and Compliance. Assists researchers in preparing submissions, responding to reviewer comments, and technical assistance throughout the process lifecycle.

Evaluates, recommends, and implements process improvements that align with the University's strategic plan to streamline processes, eliminate outdated programs, and create efficiencies.

Performs other related duties as assigned including providing back up support within unit and across the research integrity and / or compliance programs.

Minimum Qualifications

Level I

Bachelor's Degree - Business Administration, Law, Ethics, Science, Analytics, or related fields. and 2 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration. Or

Master's Degree - Business Administration, Law, Ethics, Science, Analytics, or related fields and 0 years

Level II

Bachelor's Degree - Business, Law, Ethics, Science, Mathematics, Statistics, or related field and 4 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration. Or

Master's Degree - Business, Law, Ethics, Science, Mathematics, Statistics, or related field and 2 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration.

Level III

Bachelor's Degree - Business Administration, Law, Ethics, Science, Mathematics, Statistics, Analytics, or related fields and 6 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration. Or

Master's Degree - Business Administration, Law, Ethics, Science, Mathematics, Statistics, Analytics, or related fields and 4 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration. Or

Terminal - Business Administration, Law, Ethics, Science, Mathematics, Statistics, Analytics, or related fields and 2 years of experience in research or related and supporting area, regulatory compliance, research integrity, and / or research administration.

Minimum Skills, License, and Certifications

Minimum Skills and Abilities

Level I

Strong technical skills with aptitude for expanding technical knowledge and experience in developing, designing, and / or maintaining electronic systems and electronic processes.

Ability to thoroughly and accurately analyze large data sets, effectively present analysis (written and oral), and maintain detailed project records.

Ability to lead, train, and functionally supervise as needed.

Ability to analyze submissions, determine compliance with regulations, and provide advice and guidance on how to achieve compliance.

Strong analytical, deductive reasoning, critical thinking, and active learning skills.

Ability to succeed in high-volume, high pressure, fast-paced environment to manage and prioritize a large task list with deadlines, interruptions, and competing priorities.

Demonstrated excellent oral and written communication.

Demonstrated superior active listening skills, problem sensing and solving skills, and ability to maintain strict standards of confidentiality.

Strong attention to detail and the ability to manage multiple tasks simultaneously.

Demonstrated time management, organizational, customer service skills and ability to establish and maintain effective working relationships.

Demonstrated self-discipline and sound, independent judgement completing time-sensitive assignments.

Ability to complete tasks independently as contributions to a team effort to accomplish established unit and institutional goals.

Level II

Knowledge of federal, state, local and University policies and regulations related to research compliance and / or research administration.

Knowledge of research administration, the research enterprise, legal aspects of business entities, and roles of ownership and responsibilities within business entities.

Working knowledge of human research, animal use, biological use, research integrity or ethics, the scientific method, and scientific terminology.

Knowledge of electronic compliance training and tracking systems to include COI - SMART FCOI disclosure management system, the CITI training system, and SharePoint.

Strong technical skills with aptitude for expanding technical knowledge and experience in developing, designing, and / or maintaining electronic systems and electronic processes.

Ability to thoroughly and accurately analyze large data sets, effectively present analysis (written and oral), and maintain detailed project records.

Ability to lead, train, and functionally supervise as needed.

Ability to analyze submissions, determine compliance with regulations, and provide advice and guidance on how to achieve compliance.

Strong analytical, deductive reasoning, critical thinking, and active learning skills.

Ability to succeed in high-volume, high pressure, fast-paced environment to manage and prioritize a large task list with deadlines, interruptions, and competing priorities.

Demonstrated excellent oral and written communication.

Demonstrated superior active listening skills, problem sensing and solving skills, and ability to maintain strict standards of confidentiality.

Strong attention to detail and the ability to manage multiple tasks simultaneously.

Demonstrated time management, organizational, customer service skills and ability to establish and maintain effective working relationships.

Demonstrated self-discipline and sound, independent judgement completing time-sensitive assignments.

Ability to complete tasks independently as contributions to a team effort to accomplish established unit and institutional goals.

Level III

Knowledge of federal, state, local, and University policies and regulations related to research compliance and / or research administration.