Job Summary:
This position is primarily responsible for working with Investigators and study staff to conduct ongoing quality assurance reviews and audits of research studies, assess site readiness, and develop site specific education and processes to ensure compliance with federal, state laws and Sarasota Memorial Health Care System (SMHCS) requirements. This position supports the Human Research Protection Program and is responsible for identifying opportunities to improve processes, education, and compliance related to research practice.

Required Qualifications:

• Require a bachelor’s degree in appropriate field (nursing, science, or health-related management). Relevant field experience can be considered in lieu of degree requirement on a year-for-year basis.
• Require a minimum of three (3) years of experience in an IRB Human Subject Protection role or clinical research experience with research coordination, data management, regulatory preparation, documentation, and submission to IRBs and other approval committees, as well as prior experience collaborating with numerous clinical research monitors or auditors on a variety of research studies.
• Require certification as CIP, CCRC, CCRP, CQA, or CQAP, etc., or must be obtained within two (2) years of becoming eligible.
• Require current state of Florida Registered Nurse (RN) licensure (active, eligible, or retired).

Preferred Qualifications:

• Prefer past auditing experience or similar quality assurance activities related to clinical trials.
• Prefer demonstrated knowledge of Federal regulations related to human subject protection, e.g., DHHS, FDA, as well as Good Clinical Practice guidelines (as related to research), HIPAA, etc.; or an equivalent combination of education, certification and experience from which comparable knowledge and abilities can be demonstrated.
• Prefer strong verbal, written and interpersonal communication skills and be able to communicate comfortably with physician investigators, research personnel, and officials from other departments.
• Prefer strong organizational, critical thinking, problem solving skills as well as, excellent attention to detail and ability to complete multiple tasks independently and with direction.
• Prefer demonstrated computer proficiency skills in Microsoft Word, Microsoft Office: Excel, PowerPoint, and the ability to work in IRBNet.org (internet-based software application).

Please refer the Job description for details