What are the responsibilities and job description for the Regulatory Affairs Misconduct Investigations Analyst position at Vitalief?
About Vitalief
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth.
The Role
We are seeking an experienced Regulatory Affairs Misconduct Investigations Analyst that will support our client’s (a clinical research academic university) commitment to research integrity by assisting in the assessment, inquiry, and investigation of allegations of research misconduct. The Analyst coordinates investigative activities, manages confidential records, and ensures adherence to federal, state, and institutional regulations. This role works closely with the Office of General Counsel to prepare communications and regulatory reports for federal oversight agencies.
Engagement Details
Key Responsibilities:
Research Misconduct Investigations
Regulatory Reporting & Legal Coordination
Database & Documentation Management
Required Qualifications:
Preferred Qualifications:
PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working at a computer. Standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth.
The Role
We are seeking an experienced Regulatory Affairs Misconduct Investigations Analyst that will support our client’s (a clinical research academic university) commitment to research integrity by assisting in the assessment, inquiry, and investigation of allegations of research misconduct. The Analyst coordinates investigative activities, manages confidential records, and ensures adherence to federal, state, and institutional regulations. This role works closely with the Office of General Counsel to prepare communications and regulatory reports for federal oversight agencies.
Engagement Details
- Work Hours: 20 to 30 hours per week
- Contract Duration: 6 months (possible extension)
- Pay Rate: Market competitive (depends on experience level)
- Location: 100% Remote (EST zone work hours)
Key Responsibilities:
Research Misconduct Investigations
- Provide staff support for preliminary assessments, inquiries, and investigations of alleged research misconduct.
- Coordinate meetings of inquiry committees and investigative panels.
- Facilitate forensic analyses of digital and physical evidence.
- Review and analyze case materials involving plagiarism, data falsification, or fabrication.
- Ensure proper confidential record retention in accordance with federal and institutional policies.
- Stay current with federal, state, and university regulations governing research misconduct.
Regulatory Reporting & Legal Coordination
- Collaborate with the Office of General Counsel to prepare and submit required reports to federal agencies (e.g., ORI, NSF OIG).
- Draft official communications and summaries of investigative findings.
- Ensure timely, accurate, and complete documentation of case activities.
Database & Documentation Management
- Maintain secure and well-organized records for all misconduct cases.
- Support internal tracking systems for case progress, outcomes, and reporting metrics.
Required Qualifications:
- Bachelor’s degree in law, ethics, research administration, or a related field.
- Experience in research compliance, investigations, or legal support in an academic or regulatory environment.
- Strong knowledge of federal research misconduct regulations (e.g., 42 CFR Part 93).
- Demonstrated organizational, analytical, and communication skills.
- Excellent organizational and analytical skills, strong attention to detail, and ability to manage multiple priorities.
- Strong interpersonal and communication skills; able to work effectively with a wide range of stakeholders.
- Ability to manage sensitive and confidential information with discretion.
Preferred Qualifications:
- Master’s degree, JD, or other advanced degree in a relevant field.
- Direct experience supporting research misconduct assessments, inquiries, or investigations in a university setting.
- Familiarity with forensic documentation tools, case management systems, or e-discovery platforms.
- Knowledge of federal agency oversight processes (e.g., ORI, NSF OIG procedures).
PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working at a computer. Standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.
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