Compliance Manager - FT - Days - Research Dept

Compliance Manager - FT - Days - Research Dept - 17732 DHR Health - US:TX:Edinburg - Days Job Summary Reporting to the Vice President for Research and Development, the Manager, Research Compliance must be deeply familiar with regulatory areas of research compliance related to biomedical research. The Manager will design, develop, implement, and monitor an effective research compliance program coordinating institutional-wide initiatives to assess, balance and respond appropriately to compliance risks. Responsibilities Promotes the facility mission, vision and values by effectively communicating them to others. Considers mission, vision and values in developing services, standards and practices. The Research Compliance Manager provides strategic oversight for and coordination of institutional research compliance programs that promote the highest standards of ethics, integrity and responsibility. Ability to successfully interpret and explain regulations and guidance given particular situations and audiences; ability to assess regulatory issue impact on institutional business needs, researchers, and research programs. Proven success in implementing compliance monitoring mechanisms. Exceptional written, verbal and interpersonal communication skills; demonstrated ability to effectively communicate complex issues both verbally and in writing. Demonstrated ability to design, develop, and deliver training in research compliance. Ability to identify and use formal and informal decision-making networks, facilitate reconciliation of conflicts, and negotiate successful solutions. Leadership & Oversight : Act as the primary regulatory authority within the Institute, setting the agenda for and overseeing the development, implementation, and enforcement of all SOPs related to clinical research compliance. Serve as the main point of contact for sponsors and handle concerns arising from audits. These can be serious deviations from the standard of research care and require immediate intervention to correct the situation. The incumbent will be part of the Institute’s Leadership and will report directly to a VP or EVP. SOP Development & Implementation : Design, implement, and maintain comprehensive SOPs to ensure consistent, compliant practices across the organization. Lead the teaching of SOPs and ensure all staff understand and adhere to these practices. Directly enforce adherence to SOPs and hold staff accountable. Compliance Monitoring & Enforcement : Track and monitor compliance with regulatory requirements across all research studies. Enforce compliance through regular assessments, ensuring that deficiencies are addressed promptly. Notify Clinical Research Coordinators (CRCs) of any deficiencies and ensure corrective actions are implemented. Performance Management & Tracking : Assess and grade the performance of CRCs based on their adherence to SOPs and compliance requirements. Make input into the continued employment and performance of CRCs within the organization. Assign work to CRCs and ensure they are meeting performance standards. Audit & Regulatory Interactions : Serve as the lead liaison between the Institute and external sponsors, handling concerns and communications arising from audits and regulatory reviews. Work closely with sponsors to address any findings, ensuring the Institute’s regulatory posture is protected and strengthened. Training & Education : Lead the development and delivery of regulatory training programs across the Institute. Serve as the primary resource for teaching regulatory materials, ensuring all team members are well‑versed in compliance requirements and standards. Quality Assurance & Control : Design and implement control measures to improve the Institute’s regulatory posture, particularly regarding FDA requirements. Ensure that all regulatory documentation and compliance records for clinical trials are complete and accurate. Work Assignment & Workflow Management : Assign tasks and responsibilities to CRCs, ensuring workloads are distributed effectively and timelines are met. Implement compliance schedules to track study progress and ensure that each trial is on track with regulatory requirements. Continuous Improvement & Process Optimization : Continuously assess and improve compliance processes, incorporating feedback from audits, CRCs, and sponsors. Proactively identify areas for improvement and design solutions to enhance compliance and efficiency. Comprehensive Compliance Coverage : Ensure that all aspects of compliance documentation are completed for all 250 studies, including the required regulatory filings, audit responses, and compliance reports. Collaborate with internal teams to maintain a comprehensive regulatory database. Other duties as assigned. Qualifications Minimum of Master’s degree in Health Administration with demonstrated work experience. Moderate professional experience in research administration and/or research compliance. Computer skills required with knowledge of Microsoft Office suite. Excellent written and verbal communication skills required. Some evening or weekend work will be required. Extensive knowledge of federal research regulations pertaining to one or more of the following areas: sponsored projects, research integrity, effort reporting, conflict of interest, human subject research, export control/controlled information, procurement, record retention, etc. Knowledge in clinical research contracts and management of pre and post award allocations in compliance with state, federal and private funding agencies. Knowledge of State, Federal Research guidelines. #J-18808-Ljbffr