Research Compliance Program Monitoring and OversightDevelops, implements, and maintains a comprehensive research compliance program aligned with federal, state, and institutional regulations.Monitors compliance with policies related to human subjects, animal research, biosafety, data security, and financial conflicts of interest.Coordinates with internal audit and legal departments to assess risk and ensure regulatory alignment.Conducts regular compliance reviews and audits of research activities.Ensures timely and accurate reporting to regulatory agencies (e.g., ORI, OHRP, FDA).Research Misconduct and Integrity Concerns InvestigationsLeads investigations into allegations of research misconduct, including fabrication, falsification, and plagiarism.Ensures compliance with institutional policies and federal regulations (e.g., 42 CFR Part 93).Prepares detailed investigative reports and maintains documentation for internal and external review.Coordinates with legal counsel and external agencies as needed.Recommends corrective actions and monitors implementation.Education and Training Development and DeliveryDesigns and delivers training programs on responsible conduct of research (RCR), scientific integrity, and compliance topics.Develops educational materials and online modules for faculty, staff, and trainees.Tracks participation and evaluates training effectiveness.Advises departments on best practices in research compliance.Promotes a culture of ethical research through outreach and engagement.Collaboration with StakeholdersServes as a liaison to IRBs, IACUCs, IBCs, and other research oversight committees.Partners with research administration, grants and contracts, and sponsored programs offices.Advises principal investigators and department chairs on compliance issues.Participates in institutional committees related to research governance.Supports interdisciplinary initiatives to enhance research integrity.Policies and Procedures AdministrationDrafts, updates, and disseminates institutional policies related to research compliance and scientific integrity.Ensures policies are aligned with evolving federal and state regulations.Reviews and revises standard operating procedures (SOPs) for research oversight.Coordinates policy implementation across departments.Maintains a centralized repository of compliance documentation.Regulatory and Industry Trends MonitoringStays current on changes in federal and state research compliance regulations.Analyzes emerging trends and best practices in research integrity.Advises leadership on implications of regulatory changes.Participates in professional organizations and conferences (e.g., HCCA, PRIMandR).Benchmarks institutional practices against peer organizations.Marginal or Periodic FunctionsParticipates in external audits and site visits conducted by federal agencies or research sponsors, providing documentation and institutional responses as needed.Contributes to grant proposal development by advising on compliance-related sections, including data management plans and conflict of interest disclosures.Supports crisis response efforts involving research-related incidents, such as data breaches, adverse events, or whistleblower complaints.Represents the institution at national conferences and professional forums related to research compliance and scientific integrity.Assists in the onboarding of new research faculty and staff, providing orientation on institutional compliance expectations and resources.Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency while supporting department-based goals which contribute to the success of the organization.Adheres to internal controls and reporting structure.Performs related duties as required.Knowledge/Skills/AbilitiesDemonstrated ability to adhere to an appropriate and effective set of core values and beliefs during both good and bad times; acts in line with those values; rewards the right values and disapproves of others; practices what they preach.Demonstrated ability to champion institutional integrity and transparency in all research compliance matters.Maintains confidentiality and impartiality during investigations of misconduct.Models ethical behavior and sets a tone of accountability across research teams.Ability to make good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of their solutions and suggestions turn out to be correct and accurate when judged over time.Ability to evaluate complex compliance issues and determines appropriate courses of action.Possesses functional and technical knowledge and skills to do the job at a high level of accomplishment.Demonstrated deep knowledge of federal research compliance regulations (e.g., 42 CFR Part 93, OHRP, FDA).Ability to apply technical expertise to develop and implement effective compliance programs.Ability to interpret complex regulatory language and translates it into actionable institutional policies.Must possess excellent verbal, written and interpersonal communication skills along with the ability to communicate with all levels of the organization.Demonstrated ability to think strategically and creatively, work well under pressure, and manage details of several concurrent projects.Demonstrated ability to work effectively in a team-oriented environment.Capable of working independently.Ability to work cooperatively with multi-disciplinary groups and line managers.Ability to build trust with faculty, staff, and leadership through consistent and respectful communication.Possesses effective problem-solving and conflict management skills.Strong focused listening to hammer out tough agreements and settle disputes equitably.Ability to tailor messages to a variety of audiences, including clinicians, scientists, and administrators.Ability to maintain credibility while delivering difficult compliance messages.Ability to manage multiple projects.Ability to plan, organize, set and accomplish goals.Ability to analyze/evaluate data and make appropriate recommendations.
