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Research Compliance Monitor
Location:
New York, NY
Description:
Salary : $103,889 - $128,117 Grade: 28 The Research Foundation for Mental Hygiene, Inc., is seeking a qualified candidate to fill a full-time position of Research Compliance Monitor for the NYSPI Office of Research Compliance and Integrity (ORCI). Under the supervision of the Director of the Office of Research Compliance and Integrity, the Research Compliance Monitor will ensure effective implementation and delivery of research compliance policies, setting standards according to institutional policies and applicable regulations. This Individual will work with the compliance team to prioritize tasks for timely completion and develop tools to meet regulatory and institutional requirements. The successful candidate must have advanced organizational and administrative skills and must possess excellent interpersonal skills and be able to work collaboratively with Investigative teams and research administration. Duties and Responsibilities: Responsible for the scheduling and completion of routine monitoring of study records to ensure compliance with approved study procedures and applicable regulations. Responsible for "for-cause monitoring" and ''special monitoring" including consent and procedural observation, at the request of the Director of ORCI or the IRB. Reviews submitted QA monitoring reports and training reports from investigators. Acts as a liaison between the ORCI and Investigators and research staff with regard to research compliance findings and corrective action plans. Communicates with investigators and research personnel to educate them about the monitoring program, train them to create and use self-monitoring forms, inform them of monitoring findings, and review corrective action plans. Preparing monitoring reports for IRB Full Board meetings and Columbia University Irving Medical Center Clinical Trials Office. May be responsible for review and follow-up of serious adverse event reports. Reviewing reports of protocol noncompliance for triage to the IRB Director, and Director of the NYSPI HRPP. Tracking and follow-up on special monitoring requirements, adverse event logs, protocol deviation logs, and corrective action plans. Prepares memos to communicate determinations made by the Director of ORCI or IRB regarding monitoring findings, serious adverse events, and noncompliance. Maintains files of monitoring reports and related correspondence. Maintains electronic database of serious adverse event reports and reports of noncompliance. Minimum Qualifications: A Bachelor's degree and a minimum of two years of experience working within a clinical research environment are required. An equivalent combination of related education and experience may be acceptable. Demonstrated comprehensive working knowledge of human subject protection regulations and ethical standards is required. Maintenance of current professional certification in research compliance or clinical research (e.g., CCRA, CCRP, CCRC) is required. A candidate may be hired without current certification but will be required to obtain such certification within the first 2 years of employment. RFMH employees may be required to be vaccinated for COVID-19 depending upon work location and must provide proof of vaccination. Individuals that are not vaccinated for COVID-19 are ineligible for appointment to positions that require vaccination. Fully vaccinated is defined as two (2) or more weeks since receiving either the second dose in a two-dose COVID-19 vaccination series (e.g. Pfizer-BioNTech or Moderna) or the first and only dose of a single-dose vaccine (e.g. Johnson & Johnson[J&J/Janssen]). Work Location : 1051 Riverside Drive, New York, New York 10032 To Apply : Submit an application through our website at: https://nyspi.applicantpro.com/jobs/ Please note, only applications submitted through our website will be considered. This position will be open until filled. 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. Employer/Minority/Women/Disabled/Veteran Employer. VEVRAA 41 CFR 60-300.5(a) compliant. Job Posted by ApplicantPro
Company:
New York State Psychiatry Institute
Posted:
January 25 on ApplicantList
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More About this Listing: Research Compliance Monitor
Research Compliance Monitor is a Jobs Research Compliance Monitor Job at New York State Psychiatry Institute located in New York NY. Find other listings like Research Compliance Monitor by searching Oodle for Jobs Research Compliance Monitor Jobs.
Research Compliance Monitor is a Jobs Research Compliance Monitor Job at New York State Psychiatry Institute located in New York NY. Find other listings like Research Compliance Monitor by searching Oodle for Jobs Research Compliance Monitor Jobs.