Research Integrity Specialist

Position Number: 003983

Department: Div of Research (Adm)

Employment Type: Permanent - Full-time

Months Per Year: 12

Essential Duties and Responsibilities:

The Research Integrity Specialist is responsible for quality assurance and administrative support for various compliance programs and/or processes assigned to the Office of Research Protections and Integrity ( ORPI ). This includes the Research Integrity Program (Research Misconduct and Responsible Conduct of Research) and the Human Subjects Research Protection Program.

Job Summary

Research Misconduct 30%: Program administration, daily operations, data management, and maintenance. Assist the Research Integrity Officer ( RIO ) with preliminary assessment, case management, and maintain coverage as needed. Manage inquiry panel and investigation committee meetings. Reports to federal agencies and sponsors to ensure compliance when necessary.

Responsible Conduct of Research 10%: Program administration, daily operations, data management, and maintenance. Reports to federal agencies and sponsors as needed, ensuring compliance. Tracks all required training and conducts an audit of the data provided. Develops outreach strategies and materials to ensure compliance with sponsors.

Human Subjects Research Protection 60%: Manages daily operational, administrative, and data maintenance tasks for the program, while serving as the primary backup to the IRB Manager during their absence. Analyzes complex requirements for incoming and outgoing human subjects research-related agreements—including IRB Authorization Agreements (IAAs / Reliance Agreements), Individual Investigator Agreements (IIAs), and Memorandums of Understanding (MOUs). Oversees the end-to-end facilitation, negotiation, documentation, and ongoing institutional communication to ensure full regulatory compliance. Maintains expertise in data security protocols for human subjects research, ensuring compliance regarding research apps, cloud storage, sensitive/personally identifiable information ( PII ) data handling, and secure data enclaves. Manages and implements the Post-Approval Monitoring ( PAM ) Program to maintain ongoing adherence to regulatory and institutional standards. Stay abreast of data security best practices to protect research data, including managing compliance for app usage in research, cloud-based storage solutions, handling sensitive and personally identifiable information ( PII ), and utilizing secure data enclaves.

• Administer multi-faceted research compliance programs according to institutional policies, local, state, and federal regulations and guidelines.

• Ability to investigate and resolve complex problems, including but not limited to allegations of noncompliance, protocol deviations, and adverse events.

• Assist with developing, reviewing, and maintaining policies, procedures, tools, and resources based on a changing regulatory environment.

• Provide expert advice and guidance to researchers on regulatory and sponsor requirements related to research compliance.

• Use routine interactions with stakeholders to assess their needs and provide resolutions as appropriate to the situation.

• Ability to assess unique and complex situations and recommend the most appropriate action.

• Verify program gaps and recommend to the ORPI leadership changes in program processes and procedures.

• Assist ORPI leadership in completing investigations and associated reports per applicable policies, procedures, and regulations.

• Compile information and prepare reports, records, and communication of a confidential nature to document regulatory compliance.

• Maintain paper and electronic databases and records of all applicable programs to ensure audit readiness.

• Develop and implement outreach strategies (e.g., flyers, videos, website resources) to ensure high standards of research integrity with federal regulations, state laws, and institutional policies.

Other Responsibilities

• Supervise temporary staff or graduate assistants as needed.

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

Minimum Experience / Education:

Bachelor’s degree in a related field and two years of relevant experience, or an equivalent combination of education/experience.

Preferred Education Skills and Experience:

• PhD, JD or CPI

• Work both independently and under supervision.

• Independently coordinate, manage, and complete assigned projects in a timely manner.

• Handle multiple tasks thoroughly and efficiently.

• Advanced computer and software skills, including MS Office Suite, Google Suite, and Smartsheet knowledge.

• Prior experience using infoEd Global software.

• Have excellent oral and written communication skills.

• Have strong interpersonal, communication, organization, teamwork, and customer service skills.

• Prior experience in data science, compliance, or regulations.

• Knowledge of HIPAA requirements for data handling and storage.

• Ability to maintain confidential information at all times.