SOLICITATION NOTICE
Q -- Research Coordinator/Clinical Research Coordinator for the Transfusion-Related Infections Prospective Study (TRIPS)
- Notice Date
- 3/30/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- 18-007259
- Archive Date
- 5/1/2018
- Point of Contact
- Christopher D. Lauver, Phone: 301-594-5914
- E-Mail Address
-
christopher.lauver@nih.gov
(christopher.lauver@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: SUBURBAN HOSPTIAL, INC 6800 OLD GEROGETOWN RD BETHESDA, MD, 20814-1422, UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard $15.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-97, January 24, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Research Coordinator/Clinical Research Coordinator for the Transfusion-Related Infections Prospective Study (TRIPS) 2. Background Information: The CC is a clinical research hospital providing medical services for patients participating in human research protocols at the NIH. The CC provides patient facilities, services for clinical investigations, research in related areas, and training programs for residents. The NIH Clinical Center Department of Transfusion Medicine (DTM) mission is to provide high-quality patient care and hospital services in support of NIH clinical research programs, to pursue research that contributes to our knowledge and practice of transfusion medicine and related technologies, and to provide advanced training in transfusion medicine. The DTM Infectious Diseases Section (IDS), including the Clinical Studies Section (CSS) conducts a large-scale, investigator-initiated, and collaborative research program. The long-term goals of this research program are to: 1) study and prevent transfusion-associated infections; in the past, these studies focused on transfusion-associated hepatitis, but have now expanded to investigate all potential transfusion-transmitted agents; 2) explore new technologies for the detection and study of blood-transmitted agents including gene array and deep sequencing technology; 3) characterize novel and established blood-transmitted agents, their infectivity, and their susceptibility to inactivation/neutralization; 4) prospectively study donors infected with hepatitis C virus (HCV) to determine the natural history and long-term outcome of this infection; 5) study the immunologic, virologic and gene-associated differences between HCV chronic carriers and those who spontaneously recover; 6) study mechanisms of HCV binding to B lymphocytes and downstream effects using deep sequencing and functional assays; 7) study the mechanisms of HCV binding to erythrocytes and relationship to HCV-related immune complex diseases; 8) study epidemiology and pathogenesis of transfusion-transmitted arboviruses, including Chikungunya virus, dengue virus and Zika virus; investigate the potential for infection enhancement and/or increased severity of disease with co-infection. 3. Purpose or Objective: The purpose of this procurement is to secure a full-time Research Coordinator/Clinical Research Coordinator (one personnel) for the Transfusion-Related Infections Prospective Study (TRIPS) for a period of one year. 4. Period of Performance: May 1, 2018 - April 30, 2019 CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Position Summary •The Research Coordinator will work with NIH Investigators and other research personnel to provide support and perform the responsibilities inherent in clinical research studies and specific to the NIH DTM Transfusion Related Infections Prospective Study (TRIPS) at Suburban Hospital. •The Clinical Research Coordinator is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). •While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Clinical Research Coordinator supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The Research Coordinator duties and responsibilities include, but are not limited to the following: 1.Demonstrates knowledge and understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements to maintain patient safety, confidentiality, and the integrity of the clinical trial process. 2.Plans and coordinates the initiation of the research study protocol, and the establishment of operating policies and procedures. 3.Recruits, instructs, and coordinates research subjects, as appropriate to specific study objectives and work scope. a.Implements post-operative follow-up for evaluating the incidence of transfusion-transmitted infections among patients undergoing various surgical procedures likely to require allogeneic blood transfusion. b.Performs an assessment of all potential cases analyzing the medical condition of each patient to determine their eligibility for enrollment in the study. It is anticipated that 4-6 patients will be enrolled each week at SH and that these will be sampled pre-surgery/transfusion and then at 1, 2, 4, 8, 12 and 24 weeks post c.Administers informed consent and ensures patients' understanding of all aspects of participation. d.Schedules study visits and ensures patient compliance, including collection, tracking, and storage of patient blood samples. 4.Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data. a.Obtains required source documents and completes required Case Report Forms accurately and completely. b.Maintains adequate and accurate case histories for each study participant as needed. c.Enters all required data in the study's web-based application (TRIPS 2) accurately and completely in a timely manner. 5.Ensures the smooth and efficient day-to-day operation of research and data collection activities at Suburban Hospital (SH); acts as the primary administrative point of contact for internal research staff. a.Collaborates closely and maintains communication with NIH TRIPS research team to ensure research objectives are met and study is conducted in accordance with the protocol. b.Maintains communication with SH collaborators such as surgical staff and cardiothoracic teams. 6.Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. 7.Implements quality control process throughout the conduct of the trial. 8.Participates in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities. 9.Other duties may be assigned. Period of Performance: One year with an approximate start date on or around May 1, 2018. Tour of Duty: Tour of duty will include Monday-Friday working hours and exclude government holidays. Additional Requirements This contract will be for a full-time Research Coordinator position for one year. In the event that one of the Research Coordinator is unavailable, another coordinator will step in and share the responsibilities and duties and serve as the alternate/backup Res. Coordinator at no additional cost. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This research study is ongoing and utilizing an existing research coordinator reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by April 16, 2018, 3:00 PM Eastern time and must reference solicitation number 18-007259. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/18-007259/listing.html)
- Place of Performance
- Address: 9000 Rockville Pike, BLDG 10, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04873554-W 20180401/180330231001-7babb4379003a778673997d014ec0154 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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