Job Description

Job Title: Quality Improvement and Compliance Monitor

Grade: 28

Salary: $107,005-$127,588

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.

Duties and Responsibilities:

Additional responsibilities include, but are not limited to:

• 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.

Minimum Qualifications:

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

Preferred Qualifications:

• 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

Work Location: 1051 Riverside Drive, New York, NY 10032

To Apply: Submit an application through our website at . Please note only applications submitted through our website will be considered.

The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer.

The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant.

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