| Research Compliance Manager -- Poughkeepsie, NY |
Author: Jon Merz
Date: 04-23-10 15:19
Research Compliance Manager
Vassar Brothers Medical Center (VBMC) in Poughkeepsie New York seeks a Research Compliance Manager to join the Office of Research and Analytics. The Office of Research and Analytics is a new department responsible for developing a strong quality-driven, ethical and compliant research enterprise in this growing and forward-thinking institution.
This position will be a cross-functional position ensuring compliance with all regulations related to the protection of human research subjects and other research-related areas including research budgeting and billing, and coordination between research compliance and administration. This includes maintaining VBMC and affiliates' Federal-wide Assurance (FWA) with OHRP, operating one IRB committee, conducting exemption determinations and expedited reviews, assisting VBMC and affiliate researchers and coordinators in developing appropriate procedures for their studies, and providing training to IRB members and researchers in human subjects protections.
The Office strives to maintain a collaborative and synergistic relationship with researchers and research staff with the shared goal of conducting valid, efficient, ethical and compliant human research.
Reporting to the Vice President for Research and Analytics, the IRB Manager will be responsible for managing the day to day operations of the Office, developing SOPs, and for improving IRB practices, compliance, and operational efficiencies. In collaboration with the VP, this position will be responsible for overall development of the human research protection program. We expect this IRB to eventually cover all facilities within the umbrella corporation, Health Quest in the near future.
Responsibilities:
The Research Compliance Manager would be responsible for:
* Leading efforts to develop and improve compliance with human subjects protection policies and procedures, with a focus on efficiency and continuous improvement;
* Working with corporate Compliance, Finance, and Business Office to ensure consistency across all research policies and functions and ensuring cross functional data harmonization.
* Developing, updating and maintaining the IRB SOPs to ensure accurate data management; compliance with applicable regulations, guidance and policies; efficient submissions and response processes and suggesting changes to the VP;
* Managing the day to day operations of the IRB, scheduling and managing meetings, quorum counts, member packets, agendas and minutes;
* Identifying and assessing setting-appropriate electronic IRB management systems, successfully implementing selected systems and submission processes, and ensuring that valid, informative and appropriate documents and data reports are generated;
* Applying DHHS and FDA federal regulations for the protection of human subjects to specific research situations;
* Serving as an ex officio IRB member;
* Conducting exempt determinations and expedited protocol reviews; writing all IRB-related communications including approval, disapproval, and notification letters and templates;
* Acting as the organizational resource for all research compliance issues and collaborating with researchers on all compliance issues including IRB requirements or human subjects protection issues; revising submissions including ICFs, waiver requests etc. to ensure compliance;
* Designing and planning special projects designed to enhance office procedures, IRB performance, overall human subjects protections and general research compliance;
* Developing and delivering of human subjects outreach and training programs for IRB members and research staff; and
* Providing support to the VP in all regulatory and administrative tasks.
Qualifications:
* Bachelor, preferably in a research, scientific or related
technical field or Master of Public Health;
* PhD in an analytic discipline (i.e.: epidemiology or health services research) a plus
* Certified IRB Professional (CIP) or Certified IRB Manager (CIM);
* At least 4 years of experience in IRB administration is required. Prior experience as an IRB manager or IRB coordinator for an academic, government, or commercial organization is preferred;
* Experience conducting exempt determinations and/or expedited reviews;
* Extensive knowledge of both DHHS (45 CFR 46) and FDA (21 CFR 50 and 56) human subjects regulations and appreciation of related regulatory, ethical and compliance principles;
* Familiarity with other regulations and guidance (e.g., CMS, HIPAA) that may be applicable in research studies;
* Membership in national or regional human subjects organization is preferred;
* Excellent organizational skills and strict attention to detail.
The candidate must demonstrate superior writing ability and have
demonstrated independent analytical and problem solving abilities;
If interested, contact Steven Lascher, email: Slascher@health-quest.org
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