Clinical Trials Quality Assurance Specialist

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Position Summary:
We have an exciting opportunity to join our team as a Clinical Trials Quality Assurance Specialist.

The Clinical Trials Quality Assurance Specialist for the New York Node of the NIDA-Clinical Trials Network is responsible for monitoring and facilitating the conduct of a new research protocol titled: CTN-0155: Low-threshold buprenorphine treatment at syringe services programs: a Type I hybrid effectiveness-implementation trial. This multi-site trial is planned for 8 geographically diverse domestic sites. The position is responsible for assuring that the integrity and quality of the research in this trial is maintained at the participating sites. This includes working with sites to assure that the research is conducted in accordance with Good Clinical Practice guidelines, the single-IRB approved protocol and federal regulations and guidelines. The QA Specialist understands and practices within the scope of federal regulations in regard to clinical research, understands Good Clinical Practice, is CITI trained and understands and follows the policies and procedures of the NIDA Clinical Trials Network, the CTN Clinical Coordinating Center, and the single-IRB contracted to oversee this research protocol.

Job Responsibilities:

• Serve as the Lead Quality Assurance monitor for the study, and local quality assurance monitor for each of the participating sites. Travel out of town (overnight), as needed.
• Prepare, plan, and conduct internal monitoring visits and audits of study sites (regularly scheduled and/or ad hoc, as needed)
• Serve as main point person for compliance assessments, auditing and monitoring by outside agencies (Emmes, single IRB, local IRB, and others). Assist sites in preparation of such visits.
• Act as the liaison between the participating research sites study teams and all local and external IRBs
• Identify, respond to, and participate in the resolution of potential and actual problems in regulatory and QA activities. Work with the study sites in providing necessary documentation in compliance with existing standard operating procedures, regulatory and/or data guidelines, etc.
• Disseminate guidance on quality assurance, protocol implementation, and protocol monitoring to study sites, and troubleshoot as needed
• Attend Lead Node and national protocol meetings
• Assist the NY Node Regulatory Specialist with managing regulatory requirements and critical documents related to the study
• Act as a liaison between the study sIRB and the research team, as needed. Assist the participating sites regulatory points of contact with sites applications to the single IRB and help facilitate necessary responses to the single IRB
• Provide assistance to study sites in writing local Standard Operating Procedures (SOPs)
• Assist the Lead Team with review of SOPs, templates, and organizational systems as developed for the management of regulatory and quality assurance activities, as needed.
• Draft studys Quality Assurance plan and reporting template(s)
• Maintain/enhance professional growth and development through participation in conferences, seminars, professional affiliations and internal training sessions to keep abreast of trends in the field of clinical research, addiction and project management.
• Perform other duties as assigned

Minimum Qualifications:
To qualify you must have a A Bachelors degree in a science related field and familiarity/experience working in harm reduction settings. Minimum of 10 years clinical research related experience, including experience in a key role (as project director, program manager, coordinator, QA monitor, or equivalent) for studies in the NIDA Clinical Trials Network. Strong quality assurance and regulatory skills and experience, including for multi-site clinical trials. Knowledge of clinical trials audits and site visits by study monitors. Computer literacy including word processing, spreadsheet and database management skills. Excellent analytical, interpersonal, writing and verbal communication skills. Demonstrated ability to function independently. Comprehensive knowledge of Good Clinical Practice (GCP).

Preferred Qualifications:
Comprehensive knowledge of studies conducted under the NIDA-Clinical Trials Network and experience working with the CTN Clinical Coordinating Center (Emmes) is strongly preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization.

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NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

View NYU Grossman School of Medicine's Equal Employment Opportunity (EEO) policy. Know Your Rights: Workplace discrimination is illegal.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $81,325.15 - $135,541.73 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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