SOLICITATION NOTICE
R -- Clinical Trial Specialist
- Notice Date
- 5/11/2005
- 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-05-420
- Response Due
- 5/27/2005
- Archive Date
- 6/11/2005
- Description
- This is a combined synopsis/solicitation for commercial service prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NIDDK-05-420, and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-03. The North American Industry Classification (NAICS) Code is 541611 with a small business size standard of $6.0 million. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has a requirement to procure a Clinical Trial Specialist. This position is full-time and will be for a Base Yea with Four (4) Option Years. The service is to assist senior scientists in the Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM) with the oversight and management of clinical trials and large-scale epidemiological studies in diabetes, endocrinology and metabolism. The primary responsibilities of this position include: 1. Prepare documentation of procedures for clinical trials management and data safety monitoring board to meet the needs of DEM, NIDDK, NIH and the researchers with whom they work as well as consumers, the federal government, or special interest groups. a. 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. b. Draft, review, and update DEM 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. c. Develop templates as appropriate to facilitate consistency in documentation and information collection. 2. As needed, prepare and maintain Investigational New Drug Applications and Investigation Device Exemption applications. a. Preparation of Investigational New Drug Applications (INDs) and Investigational Device Exemption (IDE) applications to the Food and Drug Administration (FDA) and if applicable, to foreign regulatory authorities. b. With assistance from established data coordinating centers, prepare IND annual reports to the FDA and if applicable, to foreign regulatory authorities. c. Ensure that all reportable Serious Adverse Events (SAEs) occurring during the conduct of collaborative clinical trials supported by DEM are transmitted to the FDA (and if applicable their foreign counterparts) in a timely manner. d. Correspond with regulatory authorities to maintain changes in study protocol and consent forms, addition of investigators and other information to keep the IND/IDE up to date. 3. In coordination with the Coordinating Center, if applicable, assist Program Officials with initiation and management of Data and Safety Monitoring Boards (DSMB) and Scientific Advisory Boards (SAC): a. To establish and maintain a central electronic database to archive documents pertaining to the following: I. Deliberations of DSMBs including meeting minutes, operating policies, II. The deliberations of SACs including meeting minutes, operating policies, III. Documents pertaining to these studies, including study protocols, rosters of DSMBs/SACs, etc. b. Assist in meeting planning, agenda development, generation of minutes, and follow-up of action items from Steering Committee meetings. c. Support dissemination of clinical trial and data safety monitoring board information to DEM customers through preparation of presentations, reports, and correspondence, and updating the website to assure accurate and timely information availability. 4. Assist Program Officials in the 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. 5. If needed, assists Program Officials in development of new study protocols. 6. Assists Program Officials in the clearance of international sites in cooperative agreements. 7. Assist Project Officials with budget monitoring of ongoing projects and development of budgets for new studies. 8. 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. 9. Maintain registration of clinical trials on clinicaltrials.gov. 10. For all of DEM, approves the DSMP and Safety Officer for all individual grants prior to the Program Official?s clearance for funding. Ensures that the Memo of DEM approval, the DSMP and the Safety Officer?s CV are placed in the official grant file. Qualifications: 1. Masters degree or equivalent in a field relevant to health sciences research. 2. At least 3 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. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications ? Commercial Items with its offer. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions ? Commercials Items, applies to this acquisition. The addenda to the clause reads as follows: The offeror must include in their quotations, the unit price, the list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items ? Deviation for Simplified Acquisitions, applies to this acquisition. The clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of furnishing the government with the service specified in this synopsis should submit their quotation to the below address. Quotations will be due fifteen (15) calendar days from the publication date of this synopsis or May 27, 2005. The quotation must reference ?Solicitation number? NIH-NIDDK-05-420. 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, Attention: Patricia Haun. FAXED COPIES WILL NOT BE ACCEPTED.
- Place of Performance
- Address: 9000 Rockville Pike, Bethesda, MD
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00804637-W 20050513/050511212001 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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