Job Description

Req# 86927

The Research Compliance Officer is responsible for designing, developing, implementing, monitoring and maintaining an effective research compliance program coordinating system-wide initiatives to assess, balance and respond appropriately to compliance risks. S/he directs all research compliance functions of the Compliance Office. S/he informs and advises the Board and senior leadership on all research compliance matters. S/he conducts research compliance risk assessments and develops compliance work plans, audits and projects, and reports conclusions and recommendations to ensure an effective, efficient and objective approach for evaluating and improving the activities of the Center. Directs all research compliance investigations. Collaborates with the Research Integrity Officer (RIO) to investigate all Research Misconduct Investigations, and to serve in an official capacity if needed. Directs, oversees and/or performs a variety of assignments to promote compliance with government rules and regulations and organizational policies and procedures. Maintains extensive and current knowledge of research compliance in health care and provides education and training to leadership, faculty and Team Members.

Responsibilities:

• Directs all components of the research compliance program in support of the Compliance Office.
• Analyzes and assesses organization activities for potential research compliance problems.
• Oversees the development and completion of research compliance work plans based on risk assessment.
• Manages internal and external compliance audit staff; evaluates performance.
• Oversees the development and delivery of research compliance education and training.
• Directs and oversees the development and maintenance of research compliance policies, information, tools and resources.
• Oversees or conducts all Research Misconduct (as defined by Public Health Services and Moffitt policy) Investigations.
• Analyzes new services, strategies and research operations to ensure compliant practices.
• Other duties as assigned.

Credentials and Experience Required:

• Bachelor’s Degree in Health Sciences, Healthcare or Business Administration, Research Administration or other related field required.
• CHC, CHRC or similar required.
• Minimum eight (8) years of relevant and progressively responsible experience in research compliance, research operations, health care compliance or other appropriate field is required.
• Minimum of four (4) years leadership experience as supervisor, team/project lead or above is required (maybe inclusive of overall experience).
• Experience conducting or overseeing regulatory audits of clinical trials.
• Experience managing complex research misconduct investigations.
• Thorough knowledge of Good Clinical Practice guidelines and basic and clinical research principles and operations.
• Thorough understanding of applicable laws and regulations surrounding research in an academic medical center environment. 
• Working knowledge of Clinical Trial Management Systems, such as OnCore. 
• Proficient in using computer software applications such as Microsoft Excel, Word, PowerPoint, Visio and Adobe. 
• Strong attention to detail, analytical skills, and the ability to interpret new laws and regulations, and communicate effectively both verbally and in writing. 
• Understanding of institutional risks and appropriate judgment to use a risk-based approach in planning and executing duties. 
• Ability to work as both independent contributor and team member. 
• Ability to communicate complex and potentially sensitive issues to all levels of management including senior leadership. Exercises patience and consistency in approach and communications. 
• Promptly and efficiently reacts to shifting priorities, demands and timelines using analytical and problem-solving capabilities. 
• Ability to effectively prioritize, execute, and assign tasks in a fast-paced, dynamic environment. 
• Excellent interpersonal and presentation skills. 
• Experience working with enterprise databases and analytics. 
• Ability to work proactively and collaboratively to fulfill the objectives of the Compliance Program and address matters with credibility, objectivity, and confidentiality in accordance with professional auditing and investigative standards. 
• Ability to abide by the highest ethical standards and exhibit these standards and the Cancer Center's mission, vision, and values in the execution of duties. 
• Exhibits positive attitude and strong work ethic.

Preferred:

• Master’s Degree in Health Sciences, Healthcare or Business Administration, Research Administration or other related field.
• Experience with Soarian, Cerner and Lawson.

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