The Research Compliance & Education Specialist position will be responsible for supporting the Director of Research Compliance in the oversight, administration and management of the HCA-HealthONE research compliance program. The Research Compliance Specialist will cultivate and maintain relationships with internal administrators and researchers as well as with external constituencies, agencies and relevant organizations. The Research Compliance Specialist effectively communicates regulations, policies, and associated requirements to IRB members and staff, investigators and research staff, facility administrators and the general HCA-HealthONE research community. The Specialist also works with the IRB Administrator to ensure that the HCA-HealthONE IRB operates within regulatory compliance.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
Responsible for assisting the Director in the development, implementation, and management of the Research Quality Improvement Program (RQIP) for the protection of human participants in research. RQIP is a training/education program for investigators and research personnel.
Develop processes to ensure that new investigators, and investigators without access to professional research support, have ready access to a knowledgeable person to help them navigate the HCA-HealthONE system and comply with federal, state, and institutional requirements.
Responsible for performing quality improvement initiatives and audits of IRB approved protocols. Conducts random and for cause audits of investigator sites and monitors the informed consent process.
Revises and updates RQIP policies and procedures in response to changes in federal and state regulations. Develops and maintains audit reporting forms and implements revisions as necessary.
Responsible for generating written audit notification to investigators, scheduling audits, communicating with research staff of all levels, compiling the final audit report, and presenting audit findings to the Director of Research Compliance, IRB and Chair, and other HCA-HealthONE Administrators as appropriate. Maintains reports, electronic records, investigator correspondence, and findings of audits conducted.
Generates correspondence and technical reports for investigators, sponsors, IRB members and other facility personnel on research protocol and compliance issues, as requested.
Maintains software system for management of IRB protocol submissions. Assists in the development of the forms utilized in the software system to ensure that all regulatory requirements are satisfied.
Responsible for maintaining up-to-date information regarding federal regulations, ethical consideration, and IRB policies related to the use of human participants in research.
Assists IRB administrative staff with the day to day processing of electronic study submissions.
Assists the Facility Ethics and Compliance Officers with research and compliance related issues.
Other non-manual administrative duties as assigned
Demonstrated working knowledge of human subject protection regulations and ethical standards.
Understanding of operational requirements related to the management and implementation of a clinical trial.
Demonstrated ability to analyze and apply regulations and ethical codes.
Proficiency in written and spoken English language and knowledge of basic medical terminology.
KNOWLEDGE, SKILLS & ABILITIES
Computer Skills: advanced Word, Excel, Outlook, and Access. Ability to utilize IRB electronic protocol submission program.
Must possess excellent writing skills for composing technical reports and correspondence.
Research process: knowledge of compliance and regulatory components of informed consent, protocols, reportable events, and submission process.
Knowledge of Good Clinical Practice guidelines and the clinical research process at the site level in order to conduct compliance audits.
Ability to interact professionally with physicians and PhD level individuals in person, via telephone and written correspondence.
Ability to work under pressure while maintaining professional standards.
Ability to research, comprehend, interpret and appropriately implement the Code of Federal Regulations. Working knowledge of the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code.
Understand the operation of the Food and Drug Administration (FDA) and the Federal Office of Human Research Protections (OHRP).
Due to the nature of the work, requires a high level of discretion when working with sponsors, investigators and other contacts, due to the confidential information and documents managed within the department.
Good critical thinking, decision making skills and strong organizational skills are essential.
Must possess strong customer service skills and have the ability to utilize problem-solving techniques.
Ability to work independently with limited supervision.
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HealthONE is an equal opportunity employer.