Loren Data's SAM Daily™

FBO DAILY ISSUE OF MAY 12, 2005 FBO #1263
SOURCES SOUGHT

R -- R -- Quality Assurance Specialist/GCP Auditor

Notice Date

5/10/2005
 

Notice Type

Sources Sought
 

Contracting Office

Attn: Department of Veterans Affairs New Mexico Health Care System, (501/90C), 1501 San Pedro Drive SE, Albuquerque, New Mexico 87108
 

ZIP Code

87108
 

Solicitation Number

501-0037-05
 

Response Due

5/18/2005
 

Point of Contact

Contracting Officer - Cesar Fausto, Contract Specialist, Ph:(505) 256-6447, Fx:(505) 248-3206
 

E-Mail Address

Cesar Fausto
(cesar.fausto@csp.research.med.va.gov)
 

Small Business Set-Aside

N/A
 

Description

The Cooperative Studies Program (CSP), a division of New Mexico VA Health Care System Office of Research and Developmentis seeking sources that are able to perform the following services: Please e-mail inquiries to Cesar Fausto at Cesar.Fausto@csp.research.med.va.gov no later then 2:00 p.m. mst on Wednesday May 18, 2005. CSP intends to contract with a GCP Quality Assurance Specialist to provide quality assurance services. This contractor will expand the current GCP Quality Assurance Program, refining all policies, procedures and tools as necessary. The contractor will have primary responsibility for the maintenance and direction of the program which shall then consist of 1) conducting GCP compliance audits at selected sites participating in the CSP trails, 2) a site monitor training program for CSP trial monitors, 3) a GCP training course for Investigators and other personnel conducting CSP trials, 4) developing study-specific procedures and tools for each new CSP study protocol to promote GCP and 5) a GCP Implementation Program for newly funded CSP trials. The GCP Implementation Program utilizes site visits by monitors or others from SMART for the purpose of training site personnel in the study-specific GCP procedures to be used in the trial. The QA Specialist will also be required to provide advice and assistance to SMART to aid in policy and program development as needed to continue or expand the GCP services of SMART. The services of an individual are being solicited rather than those of a management team or provider of professional personnel. Necessary services must be provided personally by that individual or, if volume of service exceeds the capacity of this contractor, by a subcontractor or subcontractors meeting all the qualifying criteria of the upcoming solicitation and specifically approved by The Director of SMART. It is estimated that the contractor will perform 10% to 40% of services in travel status to VA CSP study or meeting sites with the remainder of the time divided between the contractor’s place of the business and the SMART office in Albuquerque, NM as the need for frequent prolonged visits to the SMART office is anticipated. The contractor may be requested to perform up to 16 audits annually (precise locations unknown at this time), each trip requiring about 3 days in travel status and an additional 3 days for prep and follow-up. Additional travel will be required to present the GCP course at an anticipated rate of 12 courses per year. To be eligible for contract award, the candidate must have at least 5 years of experience in providing GCP Quality Assurance services to clinical research organizations. Candidate’s work history must include evidence of substantive experience in preparing and delivery GCP training programs to research professionals, reviewing paper and electronic medical records, and directing the actions of teams of monitors, auditors, or other clinical QA personnel. Additionally, at least one year of the candidate’s GCP QA experience must have involved personally providing services at a full-time or near full-time rate to federally funded research program. This experience must also have involved monitoring or auditing at VA research sites and extensive use and familiarity with the VA electronic medical records system. The candidate must also have professional certification as a Clinical Research Associate by the Association of Clinical Research Professionals or an equivalent certifying organization, and must be certified or eligible for certification in Human Subjects Protections by PRIMR/ARENA. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (10-MAY-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

RFP 501-0037-05
(http://www.eps.gov/spg/VA/AlVAMC501/AlVAMC501/501-0037-05/listing.html)
 

Place of Performance

Address: ALBUQUERQUE, NM AND VARIOUS OTHER CLINICAL SIGHTS AROUND THE COUNTRY

Zip Code: 87108

Country: United States
 

Record

SN00804211-F 20050512/050510212513 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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