Quality Improvement and Compliance Monitor

New York State Psychiatry Institute•New York, NY

78d•Onsite

About The Position

The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Quality Improvement and Compliance Monitor position for The New York State Psychiatric Institute (NYSPI) Quality Improvement and Education (QIE) team, part of the NYSPI Human Research Protections Program (HRPP), is responsible for directing the research quality and research education programs to improve overall conduct and safety of human subject research. Reporting to the QIE Director and part of the greater HRPP, the incumbent will conduct site initiation visits and post-approval monitoring reviews of human subject research projects to ensure compliance with federal regulations and guidelines and NYSPI policies. Reviews often focus on, but are not limited to, review of recruitment practices, potential participant screening, adherence to eligibility criteria and the protocol, informed consent procedures, participant safety, document storage, and confidentiality of data.

Requirements

Bachelor's degree
At least (1) year of research monitoring experience for an academic medical center, CRO or sponsor

Nice To Haves

Previous experience as a member of a research team (i.e., study coordinator/research assistant)
Thorough knowledge of state and federal codes (Revised Common Rule, FDA, etc.) regarding research.
Considerable knowledge of Good Clinical Practice (GCP)
Certification as a Clinical Research Associate (CCRA) or SOCRA Certified Clinical Research Professional (CCRP)
Advanced computer/technical skills
Strong organizational skills
Ability to communicate effectively, both written and orally

Responsibilities

Conducting for-cause audits authorized by the IRB or institutional official.
Writing reports and communicating findings with investigators, compliance committees, and appropriate parties.
Conducting education and training throughout the monitoring process with the ability to recommend for further training to the human research education committee.
Providing regulatory guidance to the NYSPI research community.
Assisting with site or study-specific research self-assessments.
Other responsibilities as assigned by the QIE Director.