| Scientific Research Manager -- New York, NY |
Author: Helen Panageas
Date: 10-12-11 18:06
The NYU School of Medicine Institutional Review Board (NYU SoM IRB) is seeking a Scientific Research Manager to review and approve expedited new submissions.
POSITION SUMMARY:
Reporting to the Associate Director of the IRB, the Scientific Research Manager (SRM) is responsible for overseeing the efficient operation of all processes related to new expedited and exempt submission items and acts as the primary liaison with the relevant investigators. SRM is responsible for the management of all new exempt and expedited submission action items and the supervision of expedited/exempt team. The SRM must ensure that approval of exempt and expedited items are processed within the expected turn around time. The SRM also provides vacation and sick leave coverage for the two other IRB SRMs.
MAJOR DUTIES AND RESPONSIBILITIES:
· Oversee day to day processes for review of all new exempt and expedited submissions.
· Conduct final review of new expedited studies and evaluate:
· The completeness and accuracy of the application and the required documentation using the IRB pre-review checklist
· The protocol, consent and other relevant documents to ensure compliance with NYU SoM policies & procedures, applicable federal, state and local law, and Good Clinical Practices
· Whether the submission requires an IND/IDE and assist PI with the application process if necessary
· Conduct final review and approval of all expedited reviews involving biomedical research.
· Oversee the processing of all exemptions.
· Make final determination on any submissions that qualify for full board review and liaise with the Senior Scientific Manager.
· Communicate all review identified deficiencies to Investigators.
· Ensure all decisions for Exempt and Expedited are relayed to PI through official IRB correspondence in electronic mail format.
· Liaise with affiliate research committees and administrative staff (CTSI, PRMC, RPRG, COIC, OCT, SPA) to identify additional deficiencies and/or to determine that requisite approvals have been received
· Communicate with researchers when necessary regarding issues.
· Conduct pre-submission reviews for any items fall within Exempt or Expedited criteria as based on federal regulations and NYU SoM IRB policy.
· Ensure that all submissions; are data entered in electronic database system on a daily basis
· Ensure all communications with researchers are logged in appropriate communication filing system.
· Review all approval and modification letters generated by staff
· Oversee the activities of the exempt and expedited staff, including training and supervising each staff’s reviews and work production and provide ongoing training and process evaluation and improvement instruction.
· Provide high-level guidance and assistance to researchers and IRB staff; through education and training.
· Provide organized and planned educational sessions for research community
· Attend annual professional conferences
· Maintain education and training to ensure current and up to date knowledge for all job related aspects.
· Work with Associate Director on special projects, policy formulation and protocol specific issues as necessary.
· Provide support and assistance for any additional work as required by Associate Director.
ABOUT NYU School of Medicine:
Founded in 1841 NYU SOM is one of the nation's leading centers of advanced biomedical learning, spans a history of excellence of more than 160 years in the education and training of physicians, in patient care, and in scientific research. NYU School of Medicine includes the Post-Graduate Medical School, founded in 1948, the Skirball Institute of Biomolecular Medicine, the Sackler Graduate School in Biomedical Sciences, and the Center for AIDS research, which is one of 13 NIH/NIAMS-designated centers for AIDS research and which has one of the nation's largest programs of clinical trials evaluating drugs to treat both HIV infections and cancer.
QUALIFICATIONS:
Minimum educational requirements include a NP, RN, BSN, BS, or MS degree or equivalent in a scientific or health care field. Previous exposure to the human subject protections field is required. Qualified candidates must have excellent organizational, managerial, time management, presentational, written and verbal communication skills as this position requires frequent interaction with many principal investigators and research staff. Excellent verbal and technical writing skills and proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.). Two + years experience in clinical research and/or IRB regulatory work preferred.Exceptional interpersonal skills required. Candidates must be flexible, open minded and creative. They should be hard working and have the ability to work independently, as well as with others. Candidates must be able and exercise sound judgment and work with confidential information. Ability to work under pressure with deadlines and to multitask on multiple projects at once is desired. Advanced computer skills are required.
The ideal candidate must possess a high degree of independent judgment, proactive abilities, discretion, superior organizational, analytical, time management, multi-tasking and interpersonal communication skills. Excellent verbal and technical writing skills and proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.) are required.
CERTIFICATIONS:
Certified IRB Professional (CIP) required (or will be required within 1 year of employment)
CONTACT:
To learn more about this position contact, Helen Panageas, Associate Director, Institutional Review Board, Human Research Protection Program at: Helen.panageas@nyumc.org
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Author |
Date |
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Scientific Research Manager -- New York, NY |
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Helen Panageas |
10-12-11 18:06 |
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