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FBO DAILY ISSUE OF JULY 14, 2007 FBO #2056
SOLICITATION NOTICE

R -- Executive Secretary-Scientific Services

Notice Date
7/12/2007
 
Notice Type
Solicitation Notice
 
NAICS
541618 — Other Management Consulting Services
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
 
ZIP Code
00000
 
Solicitation Number
NHLBI-RR-PB-2007-191-DE
 
Response Due
7/21/2007
 
Archive Date
8/5/2007
 
Description
Purpose and Objective The National Center for Research Resources (NCRR) requires a well-trained medical or scientific professional to provide recommendations, that shall be advisory in nature, and to provide oversight for three Protocol Review Committees (PRC) and one Data and Safety Monitoring Board/Observational Safety Monitoring Board (DSMB/OSMB) that serve the RDCRN. The NCRR currently oversees 6 PRCs and 2 DSMB/OSMBs that provide independent review of protocols and independent safety and data monitoring of all ongoing studies. The Contractor will server as the Executive Secretary of the three PRCs and 1 DSMB/OSMB. CONTRACTOR REQUIREMENTS This position requires experience in clinical research and protocol design/development as well as highly developed scientific and administrative skills. Timely handling of responsibilities is required as tight timelines are in place for the scientific review of protocols by outside reviewers on PRCs and timely oversight by DSMB/OSMB is required to assure the safety of the participants in RDCRN studies. This may include emergency meetings to address emerging safety concerns or occurrence of serious adverse events. Thus, the time commitment must allow flexibility. The number of studies within the network is large and requires careful planning and attention to monitoring schedules even in the absence of need for emergency review. Significant skill in the management of groups and individuals is required to assure the smooth functioning of the 4 committees. Some committees may require monthly meetings but no less frequently than quarterly meetings will be required. Careful documentation of identified conflicts of interest and management is required to prevent contamination of the independent review process. Meticulous recording of actions is required as well as timely implementation. The contractor shall review submitted protocols to assess the need for additional reviewer expertise above that available on the standing committees based on the scientific, ethical, or unique statistical issues of the protocol. If additional expertise is needed, the contractor shall make recommendations to the NCRR PRC-DSMB/OSMB Coordinator for obtaining that expertise. The contractor shall also be responsible for making recommendations for new members of committees or for needed turn over in committee. The contractor shall be responsible for drafting after each meeting a summary document for the file and a draft memorandum that conveys the recommendations of the committee to the study team for each study. Drafts must be approved by NCRR and the Chair of the Committee. After approval, the contractor as Executive Secretary of the Committee shall convey the memo to the designated recipients. The contractor shall be responsible for establishing a meeting date, time, and duration of each meeting. The RDCRN Data and Technology Coordinating Center will survey members for appropriate dates if requested and provide that input to the Contractor. However, the ultimate responsibility for establishing a meeting data and time is that of the contractor. This meeting must include the majority of members and in all cases the expertise required and the involvement of the appropriate members of the protocol team or their delegates, and appropriate NIH staff. Level of Effort: The level of effort required by this contract is based on an hourly rate for services of a scientific or medical professional to provide the required services. The number of hours is not to exceed 1,040 hours over a twelve (12) month period. The total effort, in labor hours, will be reported monthly and serve as a basis for payment. The contractor shall possess an professional degree and have clinical research and review experience. In addition, the contractor shall have the required administrative, personal, and attention to detail required for this position.
 
Place of Performance
Address: NCRR, 6701 Democracy Blvd., Room 1001, Bethesda, Maryland
Zip Code: 20892-4874
Country: UNITED STATES
 
Record
SN01340450-W 20070714/070712220657 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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