Misconduct Investigations Analyst – Regulatory Affairs

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September 15

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Vitalief Inc.

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B2B • Healthcare Insurance • Pharmaceuticals

Vitalief Inc. is a company dedicated to transforming the clinical trial landscape by improving the value and contribution of trial sites throughout the drug development lifecycle. They specialize in offering consulting services, functional service provision (FSP), and workforce solutions to streamline clinical trials, enhance patient outcomes, and deliver value for Sponsors, Contract Research Organizations (CROs), and sites. With a focus on site operations and patient care in the life sciences, Vitalief serves academic sites, community health systems, independent sites, site networks, sponsors, and CROs. Their services address challenges in research and clinical trials, providing end-to-end solutions like strategic planning, resourcing models, training, and operational solutions. Vitalief is committed to delivering more efficient, high-quality clinical trials and driving innovation in the research industry.

51 - 200 employees

🤝 B2B

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $2M Venture Round on 2023-04

📋 Description

• 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. • 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. • Maintain secure and well-organized records for all misconduct cases. • Support internal tracking systems for case progress, outcomes, and reporting metrics. • Work remotely, supporting a clinical research academic university client; coordinate with cross-functional stakeholders.

🎯 Requirements

• 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. • Availability to work 20 to 30 hours per week and to work EST zone hours. • Familiarity with forensic documentation tools, case management systems, or e-discovery platforms (preferred). • Master’s degree, JD, or other advanced degree in a relevant field (preferred). • Direct experience supporting research misconduct assessments, inquiries, or investigations in a university setting (preferred). • Knowledge of federal agency oversight processes (e.g., ORI, NSF OIG procedures) (preferred).