SOLICITATION NOTICE
A -- Non-personal service contract for a Clinical Research Consultant for the period 16 Jan 2003 to 15 Jan 2004 IAW SOW
- Notice Date
- 12/24/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- N00259-03-T-0025
- Archive Date
- 1/24/2003
- Point of Contact
- Loida Toledo, Lead Purchasing Agent, Phone 619-532-8122, Fax 619-532-5596, - Joan Balazs, SPVY, Contract Specialist, Phone 619-532-5944, Fax 619-532-5596,
- E-Mail Address
-
lctoledo@nmcsd.med.navy.mil, jbalazs@nmcsd.med.navy.mil
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-03 -T-0025(RFQ) is issued for reference purposes only. Clin 0001: Non-personal service contract for a Clinical Research Consultant for the period 16 Jan 2003 to 15 Jan 2004. Qty: 300; Unit of issue: Hours. Clin 0002: Travel Expenses: this is for trips from the contractor?s location to NMCSD Refractive surgery Center for the purpose of meeting with the refractive Surgery Center Director, Research Director, and other key personnel; qty: 1, u/I: lot , description: Contractors required to travel at government expense must pay for all travel expenses and will be reimbursed for those expenses upon completion of the travel and submission of an invoice. All invoice claims for travel must be substantiated with ticket receipts , lodging and car rental receipts. Authorized rates shall be based on the Joint Travel Regulation ( JTR). Travelers must exercise the same caution in purchasing travel for government travel as they would for personal travel. The billing method will be bi-weekly in arrears based on the actual hours rendered. The duties to be performed shall be in accordance with the statement of work. The statement of work reads. STATEMENT OF WORK, Research Consultant: 1. SCOPE OF CONTRACT: a. The work to be performed is generated at the Refractive Surgery Center, Naval Medical Center, San Diego. The contractor is a Clinical Operations Consultant who provides consultation services within the course of one year for 300 hours per statement of work. 2. HOURS: a. The contractor shall be available for consultation as needed during normal business hours: Monday through Friday, 0800?1700, pacific time. The contractor shall agree to an extension of these hours, as necessary, to ensure research deadlines are met. The contractor shall be compensated for these extended hours with compensatory time off at a later date to be mutually agreed upon. 3. DUTIES: a. Under the direction of the Director and the Research Director of the Refractive Surgery Center, Naval Medical Center, San Diego, the contractor reviews clinic operations at the Refractive Surgery Center, NMCSD to assess compliance with Good Clinical Practices (GCP)?the standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials?for IDE trials conducted under 21 CFR 812 and include data collection and management systems based upon the requirements of 21 CFR 11 to ensure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities. Further responsibilities to include: Provide a detailed report and recommendations based upon assessment to the Director of Cornea and Refractive surgery Service, NMCSD. Periodic auditing of trials to monitor data integrity and compliance with GCP, applicable government regulations and IRB requirements. Preparation of technical abstracts and PowerPoint presentations. Liaison with FDA on protocol and reporting requirements. IDE preparation, submission, and reports. Provide guidance and support of clinical operations. 4. REQUIREMENTS: Bachelor of Sciences degree in a life science with at least 10 years experience in the management of ophthalmic device clinical trials in conformance with FDA requirements and demonstrated success with IDE trials to include direct experience interfacing with FDA/Ophthalmic Devices and division of Bioresearch Monitoring. Strong experience writing protocols, preparing data collection methods, initiating and monitoring clinical trials, designing training materials, writing reports, planning and conducting investigator meetings, and interfacing with IRBs is required. Must be able to attend national / international ophthalmic meetings and meet with FDA. Experience with ophthalmic, specifically laser refractive surgery trials, is necessary. Strong writing and analytical skills are required, as well as excellent organizational skills. A demonstrated ability to work independently and to interpret and present complex data clearly is required. Must be proficient with Microsoft Office (Word, Excel, and Power Point) and be able to transmit documents via email. Must be available up to work on site in San Diego and visit other designated sites as required, up to one day a week. The contractor is not prohibited, by reason of his or her performance under this contract, from outside employment so long as there is no conflict with the performance of services under this contract. The contractor shall make no use of any Government facilities or other Government property in connection with outside employment. All financial, statistical, personnel, and technical data which is furnished, produced or otherwise available to the contractor during the performance of this contract are considered confidential business information and shall not be used for purposed other than performance of work under this contract nor be released by the contractor without prior written consent of the contracting officer . Any presentation of any statistical or analytical materials, or any reports based on information obtained from studies covered by this, will be subject to review and approval by the contracting officer before publication or dissemination. The Secretary of the Navy has determined that the illegal possession or use of drugs and paraphernalia in a military setting contributes directly to military drug abuse and undermines command efforts to eliminate drug abuse among military personnel. The policy of the Department of the Navy (including the Marine Corps) is to deter and detect drug offenses on military installations. Measures taken to identify drug offenses on military installations and to prevent introduction of illegal drugs and paraphernalia include routine random inspection of personal possessions on entry or exit. If there is probable cause to believe that the contractor has been engaged in use, possession, or trafficking of drugs, the contractor may be detained for a limited period of time until he or she can be removed from the installation or turned over to the local law enforcement personnel having jurisdiction. When illegal drugs are discovered in the course of an inspection or search of a vehicle operated by a contractor, the contractor and vehicle may be detained for a reasonable period of time necessary to surrender the individual and vehicle to appropriate civil law enforcement personnel. Action may be taken to suspend working privileges as well as installation driving privileges. Implicit with the acceptance of this contract is the agreement by the contractor to comply with all Federal and State laws as well as regulations issued by the commander of the military installation concerning illegal drugs and paraphernalia. The contractor must be able to read, write, speak, and understand the English language fluently. 5. ABSENCES AND LEAVE: The contractor will not be paid for any hours not worked including any vacation and sick leave. Your services shall not be required on the following federally established holidays: New Year?s Day, Martin Luther King?s Birthday, President?s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran?s Day, Thanksgiving Day, and Christmas Day. The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-10. The following clauses and provisions are applicable and will be incorporated into the solicitation by reference, and will be available in full text upon request. This acquisition incorporates the following FAR clauses: 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS(Oct 95); 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (Oct 95) must be completed and submitted along with the quote (please contact Loida Toledo at (619)532-8122 if a copy is needed; in accordance with FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS(Aug 96), the following clauses are incorporated by reference in paragraph (b): 52.222-26 EQUAL OPPORTUNITY ( E.O. 11246); 52.222-35 AFFIRMATIVE ACTION FOR SPECIAL DISABLED AND VIETNAM ERA VETERAN (38 U.S.C. 4212); 52.222-37 EMPLOYMENT REPORTS ON SPECIAL DISABLED VETERANS AND VETERANS OF THE VIETNAM ERA(38 U.S.C. 4212); 52.222-36 AFFIRMATIVE ACTION FOR HANDICAPPED WORKERS(29 U.S.C. 793); 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS(OCT 95). DFARS 252.204-7004, REQUIRED CENTRAL CONTRACTOR REGISTRATION (MAR 1989); FAR 52.219-19, NOTICE OF TOTAL SMALL BUSINESS SET ASIDE ( 7/96). FAR 52.232-33 , MANDATORY INFORMATION FOR ELECTRONIC FUNDS TRANSFER PAYMENT (AUG 1996). FAR 52.212-2 , EVALUATION ?COMMERCIAL ITEMS ( 1/99). The following factors shall be used to evaluate offers: 1) Past performance 2) personnel qualifications based on SOW 3) Price. Past performance and personnel qualifications based on SOW when combined have more importance that cost or price. Prior to Contract Award, the government reserves the right to review the resumes of contractor employees performing under the contract solely for the purpose of ascertaining their qualifications relative to the personnel qualifications terms of the contract. Accordingly, the contractor shall furnish such resumes and all professional requirements as stated in the Statement of Work ( SOW) to the Purchasing Agent along with their quotes. All responsible sources may submit a quote which shall be considered. See numbered note(s)1.
- Place of Performance
- Address: Contractors Address
- Record
- SN00230386-W 20021226/021224213738 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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