Research Compliance Analyst III - Hybrid - 140948

The Research Compliance Analyst III serves as an experienced compliance professional supporting oncology research conducted within an academic medical center environment. The position independently conducts research compliance audits, reviews, consultations, investigations, and educational activities related to human subjects research and clinical trials. The incumbent applies knowledge of federal and state regulations, institutional policies, and industry best practices to identify compliance risks, evaluate processes, provide guidance to investigators and study teams, and promote responsible conduct of research. The position partners closely with research leadership, investigators, clinical research staff, and other institutional stakeholders to support compliance with regulatory requirements and strengthen the overall compliance program.

• Seven (7) years of related experience, education/training, OR a Bachelor's degree in related area plus three (3) years of related experience/training. Related experience includes research compliance, clinical research administration, human subjects protections, regulatory affairs, research quality assurance, healthcare compliance, clinical trial auditing, monitoring, research privacy, FDA-regulated research, academic medical center compliance, or other experience interpreting and applying healthcare or research regulations and policies.

• Thorough knowledge of the methods, tools, and practices involved with regulatory compliance.

• Knowledge and understanding of compliance and regulatory standards across the healthcare industry or thorough knowledge within a specialty area.

• Strong project management skills and the ability to effectively manage time, organize competing priorities, address complex issues as they arise, and see projects through to completion on schedule.

• Strong interpersonal skills for collaborating effectively with managers and staff at all levels and across the organization, and with representatives of external regulatory agencies.

• Strong skills in written and verbal communications, with the ability to convey complex technical information, education, and instructions in a clear and concise manner, and to produce high-quality reports, documentation, and presentations.

• Experience conducting compliance audits, reviews, investigations, monitoring activities, or risk assessments in a research or healthcare setting.

• Experience interpreting and applying regulations governing human subjects research, including FDA regulations, ICH Good Clinical Practice (GCP), HIPAA, and the Common Rule.

• Experience supporting cancer clinical trials or oncology research programs.

• Experience reviewing research protocols, informed consent documents, regulatory binders, study records, and corrective action plans.

• Experience providing compliance consultation, education, and training to investigators, research staff, and institutional stakeholders.

• Experience working within an academic medical center or NCI-designated cancer center.

• Experience using electronic research management systems, electronic health records, audit tracking systems, and data analytic tools.

• Professional certification such as CHRC, CIP, CHC, CCRP, CCRC, or equivalent or ability to obtain within one year of hire.

• Must be able to work various hours and locations based on business needs.

• Employment is subject to a criminal background check and pre-employment physical.