University Classification: Compliance and Education Manager
Job Code: PRC3
Pay Level: 5A
Position #: 00110373
Org/Dept/Sub-dept #: 04-0213-00200
Position Reports to: Michele Countryman
Position #00160960

Position Specific Summary:

The Human Subjects Office, at the University of Iowa, has an exciting full-time opportunity for a Compliance Manager.  The Compliance Manager will provide leadership and oversight in the design, planning, promotion, and conduct of in-depth, onsite reviews of human subjects research, conducted by University of Iowa researchers.  The Compliance Manager will assess compliance with federal regulations, Institutional Review Board (IRB) requirements, University of Iowa or VA policies related to the conduct of human subjects research.  This position will also serve as the education and compliance expert with regard to federal regulations, IRB requirements, and institutional policies and procedures for the protection of human subjects involved in research.  The Compliance Manager will develop and coordinate procedures, programs, and policies to enhance investigator understanding of the HawkIRB application process and compliance with the IRB policies and procedures.

Key Areas of Responsibilities and Specific Job Tasks

Classification
Key Areas of Responsibility

Specific Job Duties and Tasks

Education

·      Develop, implement, and evaluate standard operating procedures aimed at enhancing the efficiency of the IRB application process. 

·      Identify areas of need and develop, implement and evaluate measures to improve researchers' knowledge and understanding of human subject's research protections that lead to improved compliance with IRB policies and federal regulations.

·      Oversee development of Compliance team content for newsletters and written materials and for the research community including, faculty, staff, students, HSO Staff, and IRB members.

·      Presenting educational workshops and seminars on various topics.

Monitoring Research

·      Oversee and develop a methodology for systematically conducting, analyzing, and reporting results of in-depth, on-site reviews of human subjects research projects conducted by University of Iowa investigators.

·      Oversee and conduct reviews of research projects, including but not limited to comparison of research data collection forms against source records, review of research consent documentation, and interviews with research subjects, principal investigator, and research team members.

·      Develop criteria on which research project monitoring will be based and corresponding acceptable standards and policies.

·      Serve as the Program Manager of the Compliance program charged with developing corrective measures for UI investigators not meeting acceptable standards.

·      Conduct follow-up on-site reviews and document in writing whether or not the research team has implemented suggested corrective measures.

·      Review, revise, and update IRB Compliance program policies and procedures as needed.

Data Management / Reporting

·      Generate written reports analyzing results of the monitoring process; identify strengths and deficiencies or deviations from federal regulations, IRB requirements, or university policies.

·      Facilitate effective interactions with all components of the IRB office to streamline findings of compliance audits and integrate analyses into the IRB education and application review programs.

·      Prepare monthly/quarterly/annual analyses, proof reporting documents of compliance activities.

Supervision

·      Hires, develops and manages the performance of Compliance Monitoring staff.

·      Assures Compliance and Education staff are compliant with UI policies and procedures.

·      Manages, oversees and directs the HSO Compliance staff and their workflow processes

·      Assist in budget development, provide projections and recommendations; monitor expenses for the Compliance program

Universal Competencies

Collaboration/Positive Impact

Ability to work with a variety of individuals and groups in a constructive and civil manner and utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs.

Diversity, Equity and Inclusion

Ability to work with a variety of individuals and groups in a constructive and respectful manner while appreciating the unique contribution of an inclusive workforce that brings together the talents of people across multiple identities, including: race, creed, color, religion, national origins, age, sex, pregnancy, disability, veteran or military status, sexual orientation, gender identity, or associational preferences.

Service Excellence/Customer Focus

Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner.  Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.

Technical Competencies

Communicating for Effective Relationships

(Expert/Leader)

·      Hires, develops and manages the performance of Compliance Monitoring staff.

·      Assures Compliance and Education staff are compliant with UI policies and procedures.

·      Manages, oversees and directs the HSO Compliance staff and their workflow processes

·      Assist in budget development, provide projections and recommendations; monitor expenses for the Compliance program

Data Gathering and Reporting

(Extensive)

·      Hires, develops and manages the performance of Compliance Monitoring staff.

·      Assures Compliance and Education staff are compliant with UI policies and procedures.

·      Manages, oversees and directs the HSO Compliance staff and their workflow processes

·      Assist in budget development, provide projections and recommendations; monitor expenses for the Compliance program

Research Ethics / Compliance

(Extensive)

·      Hires, develops and manages the performance of Compliance Monitoring staff.

·      Assures Compliance and Education staff are compliant with UI policies and procedures.

·      Manages, oversees and directs the HSO Compliance staff and their workflow processes

·      Assist in budget development, provide projections and recommendations; monitor expenses for the Compliance program

Problem Solving

(Extensive)

·      Hires, develops and manages the performance of Compliance Monitoring staff.

·      Assures Compliance and Education staff are compliant with UI policies and procedures.

·      Manages, oversees and directs the HSO Compliance staff and their workflow processes

·      Assist in budget development, provide projections and recommendations; monitor expenses for the Compliance program

Written Communications

(Extensive)

·      Produces written materials in business- and industry-specific technical language.

·      Ensures that written message is understood as intended.

·      Adapts writing -- language, form, style, tone -- to different audiences.

·      Uses various techniques for information dissemination and information gathering.

·      Advises others on incorporating tables, charts, and diagrams into documents.

·      Reviews the written materials of others and provides feedback and coaching.

Compliance Investigations

(Extensive)

·      Develops a system to monitor and track compliance outcomes and report trends.

·      Recommends remedies to reduce the level of compliance issues.

·      Advises on alternative actions used to solve issues and meet regulatory and legal requirements.

·      Collaborates on operational aspects of monitoring and adhering to regulatory and legal requirements.

·      Leads investigations and directs efforts to train less experienced staff members.

·      Delivers comprehensive guidelines on the investigation process.

This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be.  It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his or her supervision.  The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty.

As part of performing the key areas of responsibility and competencies described above, staff members are expected to meet reasonable standards of work quality and quantity, as well as expectations for attendance established by their supervisor.  Staff members are also expected to comply with policies governing employee responsibilities and conduct, including those contained in the University Operations Manual.

Proficiency levels are defined as:

Basic Application - Uses basic understanding of the field to perform job duties; may need some guidance on job duties; applies learning to recommend options to address unusual situations.

Working Experience - Successfully completes diverse tasks of the job; applies and enhances knowledge and skill in both usual and unusual issues; needs minimal guidance in addressing unusual situations.

Extensive Experience - Performs without assistance; recognized as a resource to others; able to translate complex nuances to others; able to improve processes; focus on broad issues.

Expert/Leader - Seen as an expert and/or leader; guides, troubleshoots; has strategic focus; applies knowledge and skill across or in leading multiple projects/orgs; demonstrates knowledge of trends in field; leads in developing new processes.

Position Qualifications

Education or Equivalency Required

A degree in a field of science or learning at the bachelor’s level, or an equivalent combination of education and experience.

Required Qualification

·      Current and relevant experience (typically 3-5 years) conducting, reviewing, and/or monitoring research involving human participants or research program coordination\administration.

·      Demonstrates the ability to communicate for effective relationships; uses a broad range of techniques in communicating complex ideas to diverse populations; facilitates communication, directness and spirit of cooperation among staff and stakeholders.

·      Demonstrates extensive knowledge and ability to problem solve, analyze and synthesize information to develop alternative resolution strategies; utilize root cause data for quality improvement initiatives.

·      Current and relevant supervision/managing performance of employees.

·      Experience (typically 1-3 years) with biomedical research design, randomized clinical trials, IRB application materials and Informed Consent Documents.

·      Demonstrates extensive knowledge of federal regulations regarding the protection of human subjects participating in research including HIPAA, FDA drug, biologic and device regulations.

Highly Desirable Qualification

·      Current IRB Professional Certification (CIP) or ability to obtain the CIP designation as soon as eligible.

Desirable Qualification

·      Knowledge of University and federal regulations regarding the protection of human subjects participating in research.

·      Demonstrates a working knowledge and ability to prepare and deliver formal and informal presentations utilizing appropriate tools and techniques.

·      Experience in coordinating a research program of high complexity, involving multiple researchers/sites/projects.

·      Master’s Degree or equivalent combination of education and experience.

See requisition # 20002550 at https://jobs.uiowa.edu

Applicable background checks will be conducted.

The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.