The Compliance Specialist assists with the development, oversight, and monitoring of compliance programs within the designated area. This position provides strategic advice and recommendations as to the adjudication and mitigation of Conflicts of Interest (COI), ensures compliance with policies, rules and regulations, and ensures policies and procedures are continuously monitored and evaluated.
Primary Duties and Responsibilities:
- Uses independent judgement to recognize and identify external (non-UM) interests of Investigators that could bias the results of externally funded research awards and human subject research (HSR) protocols.
- Assesses whether sufficient disclosure documentation is available for a COI determination, and if not, contacts University personnel and students to clarify information about a disclosure that could pose a COI.
- Reviews and comprehends scientific literature, HSR protocols and funding proposals submitted to outside entities to identify factors that might exacerbate or mitigate a COI.
- On a case-by-case basis, uses discretion to garner and summarize circumstances for presentation to the University of Miami Conflict of Interest Committee (COIC) in order to allow the determination of whether disclosed interests constitute actual COI.
- Recommends to the COIC stipulations that would mitigate the introduction of bias into the data acquisition, analysis or interpretation of research and HSR protocols. Collaborate with the Committee to develop and implement an appropriate management plan to mitigate the conflict(s).
- Executes directives resolved by the COIC, including drafting and execution of COI Management Plans, coordination of site visits and compliance monitoring of investigator compliance with executed COI management plans.
- Designs and implements improvements in communication, monitoring, or enforcement of compliance standards.
- Verifies that regulatory policies and procedures are being properly documented, implemented, and communicated throughout the University of Miami.
- Serves as alternate executive assistant to the COI Committee. Coordinate meetings, maintain records of actions, follows-up and report to Committee as required.
- Acts as liaison to and utilizes Information Technology systems of the Office of Research Administration and Research Information Technology and a variety of centrally available information (e.g., Research Reporting System, InfoEd, etc) to identify, collect and document disclosed interests.
- Assists faculty, staff and students with the federally mandated disclosure process. Monitors compliance status of UM community and ensures timely renewal of disclosure of outside interests and required training.
- Uses independent judgement to identify compliance issues that require follow-up or investigation.
- Assist the Associate Director in the preparation and presentation of educational programs to groups and individuals in the University research community. Responsible for the coordination of classes/courses and conducts training in relation to compliance standards. Tracks attendance during training.
- Maintain databases and an appropriate filing system of compliance reviews.
- Performs a range of related administrative responsibilities and database maintenance.
- Review and development of a compliance web pages.
- Other duties as assigned.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Knowledge, Skills, and Abilities:
- Ability to define problems, collect and analyze data, establish facts and draw valid conclusions to solve problems, develop plans and reports, and plan initiatives. Ability to review and evaluate performance accomplishments and determine if they meet predefined standards.
- Strong interpersonal skills; ability to collaborate well with others. Ability to express ideas and information, clearly, concisely, verbally and writing. Excellent written and verbal communication skills.
- Maintains sufficient knowledge of basic and advanced scientific principles, ethics and compliance with regulations. Maintains informed regarding trends and best practices. Assesses the potential impact of these changes on organizational processes.
- Strong skills in assessing, organizing, prioritizing multiple-tasks, projects.
- Must demonstrate leadership ability.
- Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.
Education Requirements (Essential Requirements):
- Bachelor’s Degree required with a background in Sciences or related field.
- Any appropriate combination of relevant education and/or work experience will be considered.
Work Experience Requirements (Essential Requirements):
- Two (2) years of relevant experience in a scientific/research environment required; experience in research compliance a plus.
- Experience with research in academic or hospital setting preferred.