JOB DESCRIPTION

Under the direct supervision of the IBR Deputy Director and Director of Research and reporting to the Chief Research Compliance Officer (CRCO) at Nathan Kline Institute (NKI)/OMH, along with

OPWDD/IBR

Administration, the Quality Improvement Monitor is a key position in helping to ensure that research is conducted in accordance with federal and state laws and regulations and institutional policies. The incumbent is responsible for conducting post-approval monitoring activities for human and animal research. Tasks include ongoing monitoring and observation of clinical and laboratory practices relative to approved IRB and IACUC protocols, with the emphasis on educating and building partnerships with members of the research community. The successful candidate will be ready to partner across the Institute to ensure the fastidious oversight of NKI and OMH's research operations. IBR is the research arm of the New York State Office for People with Developmental Disabilities (OPWDD). OPWDD is responsible for coordinating services for New Yorkers with intellectual and/or developmental disabilities (IDD), including intellectual disabilities, Down syndrome, autism spectrum disorders, rare genetic syndromes, and other neurological impairments. Through our Jervis Clinic, a unique Article 16, Part676 Clinic, IBR provides clinical evaluations with a multi-disciplinary approach.

NYS OPWDD IBR

provides a professional setting in a world-renowned research facility located on Staten Island, NY, on a wooded, suburban campus with free off-street parking. The compensation package includes New York State Health Insurance Program (NYSHIP) insurance, a generous sick leave and vacation package, vesting in the NYS pension fund, and a deferred compensation plan. NYS Public Employees Federation (PEF) union benefits include tuition reimbursement and dental and optical coverage. Telecommuting work plan is negotiable.

Duties and Responsibilities include:

Collaborates in the development and maintenance of the Post-Approval Monitoring Program.
Reviews reports and corrective actions.
Conducts ongoing education and training or other process improvement initiatives based on the Program's results.
Leads preparation and conducts compliance and qualityreviews, investigations of unanticipated problems and non-compliance, in a thorough and professional manner.
Writes reports with corrective actions.
Communicates findings with investigators, compliance committees, and appropriate parties and conducts education and training throughout the monitoring process with the ability to recommend further training from the education manager.
Requires some travel and on location monitoring as needed.

Telecommuting is currently allowed at up to 50% at the discretion of the supervisor but is subject to change by the Governor's office and the Office for People with Developmental Disabilities.

Preferred Qualifications:

Certified by Society of Clinical Research Associates (SOCRA), Society of Clinical Data Management (SCDM), Association of Clinical Research Professionals (ACRP), or a comparable professional organization
Direct interaction with Federal Drug Administration(FDA),National Institute for Mental Health (NIMH), orpharmaceuticalmonitors, including:
Attending monitoring visits
Responding to monitoring action items
Resolving monitoring queries
Drafting and implementing Corrective and PreventiveActionPlans (CAPAs)
Two years' experience of Compliance monitoring
Five years' experience conducting human subjects research
Experience managing multiple studies under various research protocols https://www.

linkedin.com/company/nys-office-for-people-with-developmental-disabilities/posts/?feedView=all #LI-DA1

Minimum Qualifications Non-Competitive:

Bachelor's degree and five years of professional research experience in an appropriate field.

Substitutions:

Master's degree in an appropriate field may substitute for one year of experience, and Ph.D. in an appropriate field may substitute for an additional year of experience. Additional Comments

Please note that starting salary for this title reflects the Downstate adjustment. Posted Hiring Salary includes the sum of the statutory hiring rate for PS&T Grade 27 ($106,898) and Downstate adjustment ($4,000). Downstate adjustment is added to the job rate ($131,665).
The assignment of PS&T employees will be made in accordance with any agreed upon Memorandum of Understanding between PEF and the local DDSO regarding the posting of job vacancies.
Preference will be given to OPWDD employees impacted by closures. If you are being impacted by closure, please indicate this on your resume.
All OPWDD employees must be eligible and maintain eligibility for full and unconditional participation in the Medicare and Medicaid programs. Continued employment will depend on maintaining eligibility.
If you are employed by state government you may be able to receive loan forgiveness under the Public Service Loan Forgiveness Program (PSLF).

The PSLF Program forgives the remaining balance on Direct Loans after 120 qualifying monthly payments have been made under a qualifying repayment plan while working full-time for a qualifying employer. For more information on PSLF, please visit www.studentAid.gov/publicservice.

Employees on long term leave can bid on positions but must be able to report to work within fourteen (14) days and be able to perform the essential functions of their positions with or without reasonable accommodation (RA).
If an employee or job applicant believes that they need a reasonable accommodation, they should contact the Reasonable Accommodation Unit at (518) 486-7222 or email accommodationrequests@opwdd.ny.gov to obtain information and RA forms.
Savings programs such as the U.S. Savings Bond and the College Savings Plan.
Voluntary pre-tax savings programs such as Health Care Spending Account and the Dependent Care Advantage Account offer employees options to pay for uncovered health care expenses or dependent care expenses.
Access to the Employee Assistance Program (EAP) an assessment and referral service that connects employees with local service providers and support services to address their personal needs.
Life insurance and Disability insurance.
The New York State Deferred Compensation Plan is a voluntary retirement plan that offers employees the option to invest a part of their salaries for retirement on a tax-deferred basis.

Paid Holidays and Leave:

° Thirteen (13) paid holidays each year. ° Thirteen (13) days of paid vacation leave initially. ° Five (5) days paid personal leave each year. ° Thirteen (13) days of paid sick leave each year (PEF/CSEA), which may carry over from year to year. ° Up to three (3) days professional leave each year to participate in professional development events.

Health Care Coverage:

Employees and their eligible dependents can choose from a variety of affordable health insurance programs. Employees are provided family dental and vision plans at no extra cost.

Paid Parental Leave:

Paid Parental Leave allows eligible employees to take up to 12 weeks of paid leave at full pay for each qualifying event. A qualifying event is defined as the birth of a child or placement of a child for adoption or foster care.

Retirement Program:

Participate in The NYS Employees' Retirement System (ERS), which is recognized as one of the best-managed and best-funded public retirement systems in the nation.

Professional Development and Education and Training:

NYS offers training programs and tuition assistance to eligible employees to maintain and increase their professional skills and prepare them for promotional opportunities. For more information, please visithttps://oer.ny.gov/training-and-professional-development.

Additionally, the Public Service Workshops Program (PSWP) offers certain professional training opportunities for PEF represented and M/C designated employees that may grant continuing education credits towards maintaining professional licensure. For more information, please visit https://oer.ny.gov/public-service-workshops-program-pswp.
OPWDD is an Equal Opportunity/Affirmative Action employer dedicated to creating and sustaining a culture of inclusion.

We believe that we are most effective in managing and improving our service system with a diverse team of employees. With such a large workforce, we rely on the collective individual differences, life experiences, knowledge, self-expression, ideas and talent that our employees bring to their work. This speaks to our culture and is a key part of our successes. As we continuously recruit people for our team, we welcome the unique contributions that applicants bring in terms of their education, culture, ethnicity, race, sex, gender identity and expression, nation of origin, age, languages spoken, veteran's status, color, religion, disability, sexual orientation and beliefs.

All people with disabilities are encouraged to apply.
Some positions may require additional credentials or a background check to verify your identity.

Name Staten Island DDSO Human Resources Telephone 7189835433 Fax 7189835216 Email Address StatenIsland.

Careers@opwdd.ny.gov Address Street 1150 Forest Hill Road Building 46 City Staten Island State NY Zip Code 10314 Notes on Applying Please email your resume to StatenIsland.

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