SOLICITATION NOTICE
R -- Senior Research Specialist
- Notice Date
- 3/13/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70040-NV
- Response Due
- 3/22/2007
- Archive Date
- 4/6/2007
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) proposes to acquire, on a sole source basis with Sharon Mavroukakis, Rockville, Maryland 20850 to provide senior research nurse consultant support. The Surgery Branch has a dual function in it?s investigators are involved in the conduct of laboratory and clinical research aimed at improving the management of patients with cancer, while at the same time providing surgical consultative care for patients throughout the Clinical Center. The SB is responsible for clinical care in most surgical subspecialties, including thoracic surgery, gynecological surgery, endocrinology surgery, vascular surgery, and vascular access. Laboratory research efforts emphasize studies of tumor immunology and immunotherapy, surgical metabolism, and molecular genetics. In these studies, an emphasis is placed on the translation of laboratory findings into the development of clinical protocols. Clinical efforts emphasize the development of new approaches to the immunotherapy of cancer, as well as the development of innovative surgical approaches to the treatment of patients with primary and metastatic cancer. The Surgery Branch Protocol Support Office (SBPSO) drafts biomedical research protocols for oncology clinical trials, revises protocols as needed, creates standard and ad hoc reports, and oversees study monitoring and data collection. The contractor shall support research protocol writing and revisions, draft standard and ad hoc reports, and assist in the maintenance of office documents and records. On occasion the contractor shall oversee study monitoring and/or data collection. To perform this work a contractor must meet the following minimum qualifications: The contractor shall have a college science degree master?s and a minimum of five (5) years work experience in these areas: 1) writing biomedical research protocol documents including study design and informed consents; 2) preparing applications for the following Regulatory Offices reviewing biomedical research: Office of Biotechnology Activities (OBA), NIH and Institutional Biosafety Committee (IBC), NIH and U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications; 3) preparing documents for NCI Institutional Review Boards (IRB) that comply with FDA and Office of Human Research Protections (OHRP), HHS mandated guidelines and procedures. Tasks 1 -3 require extensive knowledge of and application of the Code of Federal Regulations, Title 45, Public Welfare, PART 46, Protection of Human Subjects; TITLE 21?Food and Drugs, and NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH GUIDELINES). The tasks the contractor will be required to perform are as follows: 1) Review Surgery Branch biomedical research protocols during the development phase and make recommendations in writing: a) review formatting and content to meet the NCI IRB requirements (http://home.ccr.cancer.gov/IRB/index.htm); b) 5-10 new protocols per quarter; c ) completion of document review within seven (7) business days, with corrections returned within 2 business days; and d) recommendations will be documented in the protocol file in the Surgery Branch S: drive via remote applications (http://remoteapps.nci.nih.gov/) according to established SBPSO procedures, which will be provided to the contractor; 2) Write informed consent documents with review/input of the Principal Investigator, according to NCI IRB requirements (http://home.ccr.cancer.gov/IRB/index.htm); a) 5-10 informed consent documents per quarter; 3) Write/coordinate documents for submission and response to stipulations for the PRMC, IRB, and sponsor(s) according to agency/review body policies and procedures and established SBPSO procedures, which will be provided to the contractor; a) 10-20 documents, including Response memorandum, copy of protocol document with changes underlined, copy of protocol document with changes accepted, copy of consent document with changes underlined, copy of consent document with changes accepted; and b)Completion of document review within seven (7) business days, with corrections returned within 2 business days; 4) Draft IND submission packages according to CFR 21 Part 312 and coordinate with the Surgery Branch Protocol Support Office submission to the FDA according to established SBPSO procedures, which will be provided to the contractor. a) 3-4 IND submission packages per annum, to be completed within 2 weeks of NCI IRB approval of the research protocol. according to CFR 21 Part 312; and 5) Draft OBA applications according to NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH GUIDELINES) for assigned gene therapy research trials (http://www4.od.nih.gov/oba/Rdna.htm) and established SBPSO procedures, which will be provided to the contractor. Sharon Mavroukakis is the only known source to the NCI Researcher who possesses the skills and expertise to perform the work as outlined above. As a Senior Research Nurse, and supervisor of the Surgery Branch Protocol Support Office, Sharon acquired this specialized expertise and knowledge during her tenure at the NIH. Upon her retirement, a serious void developed causing potential serious harm to ongoing protocols and the Surgery Branch?s ability to meet federally-mandated requirements. Ms Mavroukakis is the recognized go-to expert in writing Surgery Branch research protocol documents, preparing applications for several regulatory offices, interacting with senior scientific and administrative officials at the Food and Drug Administration (FDA), the Institutional Biosafety Committee, NCI, and in the Office of Biotechnology Activities, NIH. She is also a highly-regarded expert in preparing documents for the Institutional Review Boards that must comply with FDA and Office of Human Research Protections (OHRP). She has the required knowledge of all federal regulations that are relevant to the protection of human subjects. During this contract period the SB will be training someone to fill Ms. Mavroukakis position. This item is commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program using simplified procedures for certain commercial items as authorized in FAR 13.5. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI researcher to determine if it can meet the requirements of this synopsis. An original and one copy of the capability statements must be received in the Contracting Office by 2:30 PM EDT (local Washington, D.C. time) on March 22, 2007. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award from the NCI, contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS: 541990; Size Standard is $6.5 million.
- Record
- SN01249527-W 20070315/070313220317 (fbodaily.com)
- Source
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