SOLICITATION NOTICE
R -- Clinical Trial Specialists
- Notice Date
- 12/19/2006
- 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIH-NIDDK-07-127
- Response Due
- 1/5/2007
- Archive Date
- 1/20/2007
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items 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-07-127 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 2001-27. The North American Industry Classification (NAICS) Code is 541611 and the business size standard is $6.0M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. This is set aside for Small Businesses. 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 will be set up as a Base year plus four option years. The service is to assist Program Officials in the Division of Digestive Diseases and Nutrition (DDN) with the oversight of clinical trials and Data and Safety Monitoring Boards (DSMBs) as follows: 1. Prepare comprehensive and well-researched clinical trials and DSMB 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 DSMB requirements for at least 12 multi-center clinical trials through review of documentation submitted and making recommendations to support researchers in meeting such requirements. 3. Support DDN Program Officials by assisting in establishing new DSMBs as needed. 4. Support dissemination of clinical trials and DSMB information to DDN customers through preparation of presentations, reports, and correspondence, and updating the website to assure accurate and timely information availability. 5. Support DDN Program Officials by assisting in DSMB and clinical triasltrials information collection, data organization and analysis, and preparation of reports. 6. Apply knowledge of clinical trials and DSMB requirements to support DDN Program Officials 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. 7. Apply scientific knowledge of clinical trials and DSMB requirements to support DDN Program Officials in review, analysis, and critique of documentation, and make recommendations to clarify information without changing the intent or substance of the documents. 8. Draft, review, and update DDN clinical trials and DSMB policies and procedure guidelines to assure compliance with current requirements. Prepare succinct directives for issuance through DDN or NIDDK Program Officials to assure that researchers have the information needed to comply with requirements. Develop templates as appropriate to facilitate consistency in documentation and information collection. 9. Support Program Officials? 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. Additional Duties: 1. Support the DDN administration by generating meeting summaries from DDN staff meetings. 2. Support the DDN administration by generating accurate and timely meeting summaries of the sub-council portion of NIDDK Advisory Council Meetings. 3. Support DDN Program Officials by providing services, which are equivalent to those provided to DSMBs, to Protocol Review Committees as needed. This position requires travel to participate in DSMB meetings, clinical trials steering committee and executive committee meetings, protocol review committee meetings, and other research meetings at the request of the DDN Director of the Clinical Trials Program, other supported DDN program Officials, or the DDN Division Director. Qualifications: 1. Masters degree or equivalent in 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. Required additions to the Statement of Work per the NIH EPMC working group document ?Use of Contractors in support of HSA Functions? (August 2005): 1) Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Project Officer to the Contractor?s Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action. 2) Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer. 3) The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government?s rights in any way under the other provisions of the contract, including those related to the Government?s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier. 4) The Contractor shall not develop or write an initiative (RFQ/PA/RFP). 5) The Contractor shall not determine whether applications submitted to the IC should be accepted or make any funding recommendations to the IC?s Council or Director. 6) The Contractor shall not negotiate with applicants/offerors for the budgets or award terms and conditions. 7) The Contractor shall not serve on a source selection panel. 8) The Contractor shall not provide official guidance concerning laws, regulations, NIH policies and procedures or scientific/technical advice to federal staff or applicants/offerors who are seeking funding or to grantees. 9) The Contractor shall not serve on scientific/technical committees as a representative of the IC, NIH, or the Government. The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors ? Commercial; 2) FAR Clause 52.212-2, Evaluation ? Commercial Items. As stated in FAR Clause 52.212-2(a), ?The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.? The following factors shall be used to evaluate offers: Technical Evaluation, Price, and Past Performance; 3) FAR Clause 52.212-3, Offeror Representations and Certifications ? commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions Required to Implement Statues or Executive Orders ? Commercial Items, Contract Terms and Conditions ? Commercial Items; and 5) FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items ? Deviation for Simplified Acquisitions. The offeror must include in their quotation, 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 clauses are available in full text at http://www.arnet.gov/far. Interested vendors capable of furnishing the government with the item 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 January 5, 2007. The quotation must reference ?Solicitation number? NIH-NIDDK-07-127. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 775, Bethesda, Maryland 20817, Attention: Patricia Haun. Faxed copies will not be accepted.
- Record
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