Research Integrity Specialist

The University of North Carolina

Charlotte (NC)

Hybrid

USD 54,000 - 75,000

Full time

12 days ago

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Job summary

The University of North Carolina’s Office of Research Protections and Integrity (ORPI) seeks a Research Integrity Specialist in Charlotte, NC. You will oversee program administration, data management, and investigations to ensure compliance with federal and state regulations governing human subjects research, biosafety, and research misconduct.

The role requires a bachelor’s degree (PhD/JD/CPI preferred) and strong communication skills.

Qualifications

Bachelor’s degree in a related field and two years of relevant experience.
PhD, JD or CPI preferred.
Excellent oral and written communication skills.

Responsibilities

Manage program administration, daily operations, and data maintenance for ORPI.
Investigate and resolve complex regulatory or compliance issues and noncompliance allegations.
Provide guidance on regulatory requirements and sponsor expectations.

Skills

Data management

Investigation

Regulatory compliance

Written communication

Oral communication

MS Office Suite

Google Suite

Smartsheet

Education

Bachelor's degree in a related field

PhD, JD or CPI

Tools

MS Office Suite

Google Suite

Smartsheet

infoEd Global

Job description

Please see Special Instructions for more details.

The finalist will be subject to a Criminal Background Check and/or a Motor Vehicle Report
The Search Committee will not contact references without first verifying permission with the finalist.
Please ensure your resume reflects the knowledge, skills, abilities, and experiences to support your answers to the supplemental questions.

8:00 am – 5:00 pm; Monday – Friday with occasional evening and weekend hours required, as necessary.

Hours per week 40

FLSA Status

FLSA Status Exempt

Division

Division Research

Department

Department Div of Research (Adm)

Work Location

Salary Range

Salary Range $54,249 - $75,000

Primary Purpose of Department

The Office of Research Protections and Integrity ( ORPI ) is part of the Division of Research. The office provides oversight, education, and support for integrity and compliance issues related to research at UNC Charlotte. The office ensures compliance with federal, state, and local applicable policies and laws on human subjects research, animal subjects research, biosafety, conflict of interest and commitment, research security, research misconduct, responsible conduct of research, and export control.

Primary Purpose of Position

The Research Integrity Specialist provides program support to the Office of Research Protections and Integrity ( ORPI ) by performing various administrative, technical, and analytical duties and the day-to-day management of research compliance programs at UNC Charlotte. This position reports to the Director of Research Compliance and Safety and works closely with the Research Integrity Officer, assisting with research misconduct allegations and managing proceedings. In addition, the Research Integrity Specialist is responsible for tracking and ensuring compliance with sponsors’ requirements regarding Responsible Conduct of Research ( RCR ) training. The Research Integrity Specialist will provide investigative support for the Human Subjects Research Protections Program ( HSRPP ) by conducting post-approval monitoring of IRB protocols and Interinstitutional Agreements.

Human Subjects Research – 60%: Program administration, daily operations, data management, and maintenance.
Research Misconduct – 30%: Program administration, daily operations, data management, and maintenance.
Responsible Conduct of Research – 10%: Program administration, daily operations, data management, and maintenance.

Summary of Position 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 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.
Stays 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.

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

Preferred Education, Knowledge, 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.

Necessary Certifications/Licenses

none

Preferred Certifications/Licenses

PhD, JD or CPI

Special Notes to Applicants

The finalist will be subject to a Criminal Background Check and/or a Motor Vehicle Report
The Search Committee will not contact references without first verifying permission with the finalist.
Please ensure your resume reflects the knowledge, skills, abilities, and experiences to support your answers to the supplemental questions.

If time-limited please indicate appointment end date

Contact Information

Required fields are indicated with an asterisk (*).

Required Documents