SOLICITATION NOTICE
R -- Clinical Trial Specialist
- Notice Date
- 3/22/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- NIH-NIDDK-05-402
- Response Due
- 4/18/2005
- Archive Date
- 5/3/2005
- Description
- The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement to procure the services of a Clinical Trial Specialist. This position is full-time and is expected not to exceed one (1) year. The service is to assist Project Scientists and Project Directors in the Division of Kidney, Urologic and Hematologic Diseases (DKUHD) with the oversight and management of clinical trials and large-scale epidemiological studies in nephrology and urology. The primary responsibilities of this position include: 1) Preparation of Investigational New Drug Applications (INDs) and Investigational Device Exemption (IDE) applications to the Food and Drug Administration (FDA). The preparation of similar applications to foreign countries, when necessary, is also required. 2) With assistance from established data coordinating centers, prepare IND annual reports to the FDA (as well as reports to foreign regulatory agencies, when necessary). 3) Ensure that all reportable Serious Adverse Events (SAEs) occurring during the conduct of clinical trials supported by DKUHD are transmitted to the FDA (and their foreign counterparts, when necessary) in a timely manner. 4) Correspond with the FDA (and their foreign counterparts, when necessary) to maintain changes in study protocol, addition of investigators and other information to keep the IND up to date. 5) Interact with clinical trial investigators and the NIDDK Central Repository contractors to ensure timely archiving of biologic specimens and data. In addition, the clinical trials management specialist will work with investigators to ensure appropriate informed consent documents to permit archiving are developed and executed. 6) Interface with the Office of Technology Development and Transfer, NIDDK and private sector collaborators to facilitate the execution of Clinical Trials Agreements, Material Transfer Agreements, and Cooperative Research and Development Agreements. 7) Establish and maintain a central electronic database to archive documents pertaining to the deliberations of Data and Safety Monitoring Boards (DSMBs) established for multi-center clinical trials including meeting minutes, operating policies, etc. 8) Establish and maintain a central electronic database to archive documents pertaining to the deliberations of Scientific Advisory Committees (SACs) established for large-scale epidemiological studies including meeting minutes, operating policies, etc. 9) Establish and maintain a central electronic database for multi-center clinical trials and large-scale epidemiological studies of documents pertaining to these studies, including study protocols, rosters of DSMBs/SACs, etc. 10) Assist Project Directors with budget monitoring of ongoing projects and development of budgets for new studies. 11) Serve as executive Secretary for DSMB functions. 12) Participate in site visits to participating centers. 13) Track the status of ancillary studies. 14) Maintain registration of clinical trials on clinicaltrials.gov. 15) Prepare reports on the status of studies using data available from the participating clinical centers and the data coordinating center. Qualifications: 1. Masters degree is desirable. 2. At least four (4) years of experience in clinical trial implementation. 3. Evidence of skill in technical writing related to clinical trials. 4. Ability to organize and carry out multiple concurrent long term projects. All vendors that are capable of providing the Government with the services described above may request a copy of the Request for Quote (RFQ) in writing or by FAX to 301-480-4226 to the Contracting Office prior to the closing date of this notice. It is anticipated that RFQ NIH-NIDDK-05-402 will be available fifteen (15) days after the publication date of this synopsis. Receipt of quotations will be due ten (10) days after the release of the RFQ. The anticipated award date is April 22, 2005. Quotations must be submitted in writing to the National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 774C, Bethesda, Maryland 20817 Attn: Patricia Haun. Fax quotations must contain offerors names, address, telephone number and fax number. FAX quotations will only be accepted if dated and signed by an authorized company representative.
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, MD
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00773143-W 20050324/050322211823 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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