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B -- Project Coordinator/ Data Research Assistant

Notice Date
Notice Type
561320 — Temporary Help 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, Maryland, 20852
ZIP Code
Solicitation Number
Archive Date
Point of Contact
Ashley L. Virts, , Malinda L Holdcraft,, Phone: (301) 402-4509
E-Mail Address
virtsa@mail.nih.gov, holdcram@exchange.nih.gov
Small Business Set-Aside
The National Cancer Institute (NCI), Surgery Branch (SB) plans to procure on a sole source basis, services of a Project Coordinator/Data Research Assistant with Aerotek Inc.; 7301 Parkway Dr.; Hanover, MD 21076-1159. The supplies herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-(b)(1). The North American Industry Classification System Code is 541990 and the business size standard is $6.5M. The NCI Surgery Branch has a dual function at the NIH. Investigators in the branch are involved in the conduct of laboratory and clinical research aimed at improving the management of patients with cancer. In addition, the Surgery Branch has a major commitment to providing surgical consultative care for patients throughout the Clinical Center and is responsible for clinical care in most surgical subspecialties, including thoracic surgery, gynecological surgery, endocrinology surgery, vascular surgery, and vascular access. The NCI, SB, Immunotherapy Section has numerous clinical studies which are in various stages of implementation. The Immunotherapy section supports approximately 10-15 protocols per year. Accurate and efficient management of the clinical trial data is an essential part of every clinical trial, and ensures quality of the clinical trial results. Clinical data must be carefully reported, recorded on case reports forms, checked for quality and entered into a data analysis system in order to produce reports for review by the investigators, sponsors and the regulatory authorities (Food and Drug Administration, Institutional Review Board, Office of Biotechnology Activities, Institutional Biosafety Committee). These reports are used to assess the safety and effectiveness of investigational agents in patients with cancer. Contractor shall provide: 1) Application of clinical data management concepts, methods and practices in a clinical research protocol environment on a daily basis; 2) Processing, tracking and validating data on complex clinical research protocols using the Immunotherapy Data Management System; Abstraction and interpretation of various types of data such as demographics, clinical laboratory values, anatomic pathology findings, discharge summaries, radiology reports from NIH medical records, the NIH Clinical Research Information System (CRIS) and documents submitted from referring physicians; 3) Adherence to Good Clinical Practice standards for data management of clinical research by ensuring patient confidentiality and data privacy and monitoring signed, informed protocol consents for proper patient identification, amendment versions, signatures and dates, and; 4) Provide process evaluation for the improvement, refinement, and standardization of data management procedures and systems in the NCI SB. Ė These procedures and systems include, but are not limited to, the following: Case Report Form (CRF) design, CRF completion, CRF review, data editing and proofing, data entry, pre-audit processes, adverse event recording process. Minimum Contractor Requirements: 1) Contractor shall have at least five (5) years of on the job experience and a high school education, (the contractor would need to provide evidence of these requirements via a work history documenting experience); to understand the study objectives, eligibility requirements, study implementation, data collection, evaluation, and reporting requirements. 2) Working knowledge and demonstration of a high level of proficiency. This will be measured by accurate and timely completion of CRFs. in using the data files located at the NCI and the text editing software application specifically used to view and store the Immunotherapy clinical data files. 3) Shall have required knowledge of federal regulations, 21CFR312 and Good Clinical Practice that are relevant to data management and confidentiality as it pertains to human subjects. Aerotek Inc. is the only source known to the NCI that can provide the above services for a data research assistant. Aerotek Inc, and itsí employees are recognized in data management processes and the systems utilized. Aerotek, Inc. has provided the NCI with support to the clinical fellows and attending physicians during the tumor measurement process, which is crucial to determining clinical effectiveness of our experimental treatments. They also have experience interacting with monitors and sponsors, and reconciling data amongst several databases. Changing variables at this time will be detrimental to the current studies and practices within the NCI Immunotherapy Section. Period of Performance shall be for twelve (12) months from date of award. Only one (1) award will be made as a result of this solicitation. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11: 00 a.m. ET on July 30, 2008. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Malinda Holdcraft: holdcram@exchange.nih.gov. It is the vendorís responsibility to ensure questions have been received. A determination by the Government not to compete this proposed requirement 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. No collect calls will be accepted. In order to receive an award, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-80115-NG on all correspondence.
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