University Classification: Senior Compliance and Education Specialist
Job Code: PRC2
Pay Level: 4A
Position #: 00197706
Org/Dept/Sub-dept #: 04-0213-00200
Position Reports to: Jennifer Bowman-Reif
Position #00110373 

Position Specific Summary:

The Human Subjects Office (HSO) is seeking a Senior Compliance Specialist, to specialize with ClinicalTrials.gov, to develop and coordinate programs that will enhance investigator understanding and compliance with ClinicalTrials.gov, the HawkIRB application process, and Institutional Review Board (IRB) policies and procedures. The Senior ClinicalTrials.gov Compliance Specialist will act as the education and compliance expert with regard to ClinicalTrials.gov, federal regulations, IRB requirements, and University of Iowa policies and procedures for the protection of human subjects involved in research. Occasional in-state and out-of-state travel is required to attend conferences and meetings. 

Key Areas of Responsibilities and Specific Job Tasks

Classification
Key Areas of Responsibility

Specific Job Duties and Tasks

Education

· Assist the IRB Compliance Manager with developing, implementing, and evaluating educational programs and materials aimed at enhancing the efficiency of ClinicalTrials.gov and the IRB application process as well as educating IRB members on ClinicalTrials.gov, federal regulations, and institutional policies related to human subjects research protections.

· Assist in planning and presenting educational workshops and seminars on various subjects as assigned, including ClinicalTrials.gov topics such as protocol registration and results reporting.

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

Monitoring Research

· Conduct reviews of research projects, as it relates to ClinicalTrials.gov compliance with principal investigators, and research staff.

· Assist in evaluating monitoring procedures and methods related to ClinicalTrials.gov compliance on an ongoing basis; recommend and implement new or revised procedures as needed.

· Inform and maintain internal policies and SOP's intended to forge institution-wide compliance with ClinicalTrials.gov, federal regulations and other policies as appropriate. This will include the development of recommendations for corrective actions and ensuring appropriate follow-up. 

Communication with Research Community

· Design and implement a communication plan for facilitating researchers' compliance with ClinicalTrials.gov reporting requirements and federal regulations. 

· Develop and maintain ClinicalTrials.gov content on the HSO's website.

· Convene and oversee an institutional ClinicalTrials.gov working group and document milestones as appropriate.

· Interact with appropriate entities or agencies to resolve ClinicalTrials.gov-related compliance problems.

· Participate in National Clinical Trials Registration Taskforce - a monthly conference call of clinical trial registration experts at Academic Medical Centers (AMC) that focus on clinical trials registration and results reporting issues. 

· Work with other departments to enhance existing IT systems and develop reports/metrics/tracking mechanisms to ensure compliance with ClinicalTrials.gov reporting and registration.

· Serve as a Liaison with NIH ClinicalTrials.gov team to support ClinicalTrials.gov at the institution.

Regulatory

· Collaborate with the IRB Compliance Manager to monitor new legislation or changes in regulations that might affect the institution's compliance in regards to ClinicalTrials.gov, recommending changes to administrative policies and procedures, as appropriate.

· Provide Expert interpretation for guidance on clinical trials registration requirements from various entities, including: Food and Drug Administration Amendments Act (FDAAA), International Committee of Medical Journal Editors (ICMJE), Centers for Medicare & Medicaid Services (CMS), and National Institutes of Health (NIH).

· Contribute to strategic planning efforts within the institution related to maintaining compliance with ClinicalTrials.gov.

· Provide guidance to the research community to ensure compliance with 45 CFR46.116(h), posting of clinical trial informed consent forms.

· Generate written reports analyzing results of reviews; identify strengths and deficiencies or deviations from ClinicalTrials.gov registration and results reporting requirements.

Data Management / Reporting

· Create and oversee an institution-wide system/database for ClinicalTrials.gov tracking and metrics. Advise the IRB Compliance Manager of deficiencies.

· Using the Protocol Review & Results System (PRS):

o Create accounts;

o Review, approve, and release records;

o Provide registration and results reporting assistance, as needed;

o Contact record owners when there are problems;

o Work with investigators to respond to problems and correct records;

o Provide investigators with tools and resources for results reporting and one-on-one assistance, as needed.

· Oversee internal tracking for reporting and ongoing follow-up with study teams regarding registrations and results reporting and posting of the informed consent forms. 

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

(Extensive)

· Communicates effectively with diverse audiences, using appropriate media and language; ensures important messages are clearly understood.

· Coaches others on methods to improve their own communication.

· Establishes and maintains productive working relationships within and outside of own area.

· Seeks out what's common in conflicting points of view to address and resolve issues.

· Resolves potentially harmful differences between individuals and groups of people.

· Establishes and maintains credibility and is able to influence individuals inside and outside own group and earns their respect.

Data Gathering and Reporting

(Working)

· Participates in projects to gather data for needs analysis.

· Customizes data fields to meet clients' needs.

· Interprets and explains results of a data-gathering initiative.

· Assesses common problems and obstacles surrounding data-gathering.

· Detects and summarizes patterns in data and findings by producing simple reports.

Research Ethics / Compliance

(Working)

· Applies policies and procedures designed to ensure compliance with ethical laws, regulations, and university code.

· Describes several types of issues covered by local or external IRB, ClinicalTrials.gov, etc. and organizational code for research ethics/compliance.

· Documents the ethical considerations involved in carrying out research activities.

· Follows procedures for reporting violations.

· Participates in resolving issues involving research ethics/compliance.

Training Delivery

(Extensive)

· Delivers training modules from existing lesson plans.

· Designs methods for assessing the effective delivery against stated objectives.

· Advises on adult learning principles and delivers relevant examples for learning and development.

· Evaluates the effectiveness of modules, while supporting training materials.

· Analyzes feedback and suggestions to course developers on potential improvements.

· Reviews proficiency and creativity in handling multiple skill levels in the same class.

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

(Working)

· Analyzes compliance issues using a fact-finding model.

· Produces accurate and appropriately detailed documentation to support investigations and findings.

· Follows proper protocols and informs others of potential outcomes on a 'need-to-know' basis.

· Diagnoses situations or conditions involving potential regulatory and legal implications and risks.

· Assists a more experienced investigator in complicated investigations.

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

NOTE: Education OR experience may be increased or decreased by one level for most positions.

Education or Equivalency Required

A Bachelor’s degree in a health-related or clinical field (such as nursing, biomedical sciences, medical laboratory science, radiation sciences, human physiology, or behavioral or public health with a clinical/health emphasis) or related field or an equivalent combination of education and experience is required.

Required Qualification

· Demonstrate typically 1-3 years of current and relevant experience (generally within the last 5 years), in human subjects research.

· Demonstrate typically 1-3 years of current and relevant experience (generally within the last 5 years), with analysis and reporting of clinical trial data (examples given, randomized clinical trials, or complex clinical trials), including standard mathematical concepts and statistics.

· Demonstrates knowledge of federal and state regulations governing clinical research, and Good Clinical Practice (GCP) guidelines.

· Demonstrate excellent communication, interpersonal, and relationship management skills, and ability to interact positively with a diverse population.

· Demonstrate expert proficiency with Microsoft Office software, (Excel, Outlook, Word, PowerPoint, etc.).

· Demonstrate working experience with web-based frameworks, protocols, and tools, with the ability to teach other users.

Desirable Qualification

· Knowledge of university and federal regulations regarding the protection of human subjects participating in research including; HIPAA, FDA drug, biologic and device regulations.

· Experience conducting and/or monitoring research involving human participants.

· Experience in preparing and reviewing materials for NIH grants and publications.

· A master’s degree in a health-related or clinical field (such as nursing, biomedical laboratory science, radiation science, human physiology, behavioral or public health with a clinical/health emphasis).

See requisition # 19005046 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.