MODIFICATION
R -- CLINICAL TRIAL SPECIALIST
- Notice Date
- 3/19/2013
- Notice Type
- Modification/Amendment
- NAICS
- 561320
— Temporary Help 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, Maryland, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- MIHLM2013679
- Archive Date
- 4/4/2013
- Point of Contact
- V. Lynn Griffin, Fax: 301-480-8501, MAXWELL KIMPSON,
- E-Mail Address
-
griffinv@mail.nih.gov, Max.Kimpson@nih.gov
(griffinv@mail.nih.gov, Max.Kimpson@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- MODIFICATION: Amendment one is hereby issused to address questions that have been raised as a result of the release of this Request For Quote (RFQ). 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 NIHLM2013679 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 2005-66. The North American Industry Classification (NAICS) Code is 561320 with a size standard of $12.50 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 Digestive, Diabetes & Kidney Diseases (NIDDK) has a requirement to procure the services of a Clinical Trial Specialist. 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. Responsibilities : 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. Prepare and maintain Investigational New Drug Applications and Investigation Device Exemption applications. 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). Assist Program Officials in the interface with the Office of Technology Development and Transfer. Assist Program Officials in development of new or modified study protocols and informed consent documents. Qualifications: Master degree or equivalent in a field relevant to health sciences research; At least 5 years of experience in clinical trials oversight or equivalent; Evidence of skill in technical writing related to clinical trials; Ability to organize and carry out multiple concurrent long term projects; Experience with helping prepare regulatory submissions to the FDA and oversight submissions to a DSMB; Experience in reviewing consent documents and assisting clinical sites in preparing and submitting IRB documents; Experience with human islet transplantation trials, including study design issues, informed consent issues and regulatory requirements; Experience with coordinating efforts in multi-center phase I-II and phase III (pivotal) clinical trials between clinical sites, the coordinating center and two or more Institutes at the NIH; Period of Performance: April 5, 2013 to September 30, 2013 Must be available for U.S. and International travel to visit clinical trial sites. The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors - Commercial items; 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 advantageous to the Government, price and other factors considered. The following factors will be used equally to evaluate offers: Technical Evaluation, Price, and Past Performance. The contract type is Firm Fixed Price. The select will be made on a Best Value basis with Technical Approach being the most important factor. Note: Past Performance Information: Vendors must submit a listing of the most recent contracts/awards (minimum of 3) which demonstrate similar work in nature to this Solicitation. Contracts/awards may include those entered with the Federal Government, state and local governments and commercial concerns. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 3) FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; 5) FAR Clause 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions. The Dun and Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN) and the certification of business size shall be included. The clauses are available in full text at http://www.arnet.gov/far. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) http://www.ccr.gov Interested vendors capable of providing the Government with the items 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 March 20, 2013 at 11:00 a.m. EST. Offersors shall provide an original and two copies of your quotation. The quotation must reference Solicitation number MIHLM2013679. 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 Institutes of Health, National Library of Medicine, 6707 Democracy Blvd., Suite 700W, Bethesda, Maryland 20892, Attention: V. Lynn Griffin. Faxed copies will not be accepted. Confidentiality - No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDDKD/MIHLM2013679/listing.html)
- Record
- SN03015229-W 20130321/130319235204-4ab1e0b18250bc06815bd4bab5809f7e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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