Under limited supervision, responsible for developing and presenting educational materials to compliance officials, staff, regulatory committee members, and the research community to increase awareness of, and compliance with human subject, laboratory animal, or biologically infectious agent regulations. May lead or mentor lower level team members. Responsibilities Ensures the institution's compliance with policies regarding the use of human subjects, laboratory animals or biologically infectious agents in research.
Develops and implements compliance program components including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the regulations and the institution's policies and procedures. Provides education, advice and assistance to compliance officials, regulatory committee members, investigators, research staff, and office staff to increase awareness of, and compliance with human subject regulations; integrates lessons learned into educational materials.
Evaluates processes and policies, and recommends changes; impacts budgeting, controlling costs, planning, scheduling, and procedural change. Secures the cooperation of and coordinates with applicable institutional offices, affiliated institutions, or regulatory/accrediting agencies. Assists in preparation of information and reports for grant submissions and or budget analysis.
Performs all other duties as assigned. Requires significant research regulatory knowledge. Research-related work experience within a large multiple affiliate organization.
Working knowledge of complex Federal, State and Local research and HIPAA related regulations. Ability to identify, analyze, and solve problems and work independently. Able to multitask and set priorities in a highly demanding environment.
Excellent verbal, written and interpersonal communications skills. Familiar with medical terminology. Proficient in using Microsoft Office (Word, Excel, PowerPoint) and databases.
Working knowledge of IRB regulations and obtaining informed consent.
Bachelor's degree or equivalent is required.
Three (3) years of related experience is required. Licenses &
CIP, CPIA, CCRC/CCRA, or CCRP) is preferred.
Full time