SOLICITATION NOTICE
R -- Clinical Trials Specialist Services
- Notice Date
- 6/16/2004
- 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-04-223
- Response Due
- 7/14/2004
- Archive Date
- 7/29/2004
- Point of Contact
- Diana Ly, Contract Specialist, Phone 301594-7730, Fax 301-480-8261,
- E-Mail Address
-
LyD@extra.niddk.nih.gov
- Description
- The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have a requirement to procure the services of a Clinical Trials Specialist. This position is full-time and is expected not to exceed one (1) year. The service is to assist senior scientists in the Division of Digestive Diseases and Nutrition (DDN) with the oversight of clinical trials (e.g. A Multi-Center Therapy Trial for Acute Liver Failure, Multicentered Randomized Trial of High-Dose Urso in PSC, The Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis, and the Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C) and data safety monitoring boards as follows: 1. Prepare comprehensive and well-researched clinical trials and data safety monitoring board documentation to meet the needs of DDN, NIDDK, NIH, and the researchers with whom they work as well as consumers, the federal government, or special interest groups. This may include reports, minutes from meetings and conferences, summaries, directions for completion of forms, reports, or other research documentation, updates, and presentations. 2. Support tracking and management of compliance with at least 12 multi-center clinical trials and data safety monitoring board research requirements through review of documentation submitted and assistance to researchers in meeting such requirements. 3. Support dissemination of clinical trial and data safety monitoring board information to DDN customers through preparation of presentations, reports, and correspondence, and updating the website to assure accurate and timely information availability. 4. Support DDN senior scientists by assisting in data safety monitoring board and clinical trials information collection, data organization and analysis, and preparation of reports. 5. Apply knowledge of clinical trials and data safety monitoring board requirements in review, analysis, and critique of documentation, and make recommendations for changing the documentation to meet compliance with those requirements without changing the substance of the documents. 6. Apply scientific knowledge of clinical trials and data safety monitoring board requirements in review, analysis, and critique of documentation, and make recommendations to clarify information without changing the intent or substance of the documents. 7. Draft, review, and update DDN clinical trials and data safety monitoring board policies and procedure guidelines to assure compliance with current requirements. Prepare succinct directives to assure that researchers have the information needed to comply with requirements. Develop templates as appropriate to facilitate consistency in documentation and information collection. 8. Support senior scientists? involvement in scientific meetings through all aspects of meeting planning, agenda development, compilation of information, documenting discussion and generating minutes, distribution of minutes, and follow-up on action items identified. Qualifications: 1. Masters degree or equivalent in nursing or a field relevant to health sciences research. 2. At least 2 years of experience in clinical trials oversight or equivalent 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 301-480-8261 to the Contracting Office prior to the closing date of this notice. It is anticipated that RFQ NIH-NIDDK-04-223 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 July 14, 2004. Quotations must be submitted in writing to the National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 773, Bethesda, Maryland 20817 Attention: Diana Ly. 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: 6707 Democracy Boulevard, Bethesda, MD
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN00604350-W 20040618/040616211843 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |