Research Scientist 4

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

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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.