MODIFICATION
A -- Clinical Operation Consultant
- Notice Date
- 8/29/2003
- Notice Type
- Modification
- 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-0091
- Response Due
- 9/10/2003
- Archive Date
- 9/25/2003
- Point of Contact
- Laura Pruett, Purchasing Agent, Phone 619-532-8110, Fax 619-532-5596, - Frank Aspuria, Supervisory Contract Specialist, Phone 619-532-8093, Fax 619-532-5596,
- E-Mail Address
-
lmpruett@nmcsd.med.navy.mil, fcaspuria@nmcsd.med.navy.mil
- Small Business Set-Aside
- Total Small Business
- Description
- The proposed contract action is for supplies or services for which the Naval Medical Center San Diego intends to solicit with only one source, Vincetta M. Lombardo, Clinical Ops Consultant, under the authority of FAR 6.302. Interested contractors/persons may identify their interest and capability to respond to the requirement or submit quotations. This notice of intent is not a request for competitive quotations. However, all quotes received August 28, 2003 @ 2:30 p.m. Pacific Standard time, closing date extended to September 10, 2003 @ 3:30 p.n. Pacific Standard time, to be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. 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 only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-03-T-0091 is issued as a request for quotation (RFQ). Clin 0001. Non-personal services for a Clinical Operations Consultant for the period from September 22, 2003 thru January 23, 960 hours @ $___ hr = $ ___. The duties to be performed shall be in accordance with the statement of work, (SOW). The services and duty hours will be performed at Naval Medical Center San Diego, Refractive Surgery Center, Branch Medical Clinic, Bldg 624-2, 2650 Stockton Road, San Diego, CA 92106. STATEMENT OF WORK, Clinical Trials Regulatory Affairs Director, Ophthalmology Department PRK Program SCOPE OF WORK This is a non-personal service contract for a Clinical Trials Regulatory Affairs Director who provides senior level assistance and direct patient care services as an investigator in support of refractive surgery trials requiring an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). The contractor will be under the guidance of the Director of Refractive Surgery, NMCSD. The primary work location is the Branch Medical Clinic, Naval Training Center San Diego. Secondary work locations are the Naval Medical Center San Diego (Balboa Hospital) and other clinical sites involved in collaborative research projects including Walter Reed Army Medical Center, Washington DC, and Wilford Hall Air Force Medical Center, San Antonio, TX. DUTY HOURS The contractor shall be available for duty at the Naval Medical Center, San Diego, the Naval Training Center, San Diego, CA, or other clinical sites or locations as directed by the Director of Refractive Surgery from 0730-1630 (this includes a one-hour lunch), Monday through Friday. The contractor shall agree to modify these hours, as necessary, to ensure clinical and/or regulatory requirements are completed or deadlines met. If the contractor is required to stay past the normal work hours, the contractor will be compensated with commensurate leave at a later date to be mutually agreed upon. The contractor shall arrive for each scheduled shift in a well-rested condition and shall have had at least six hours of rest from all other duties immediately prior to reporting for the shift. The total number of working hours in a 1-year contract will be 1800. Working hours will be verified by the Director or the Research Director, Refractive Surgery Center, Naval Medical Center San Diego. Invoices will be submitted biweekly. DUTIES The contractor shall have primary responsibility to manage NMCSD refractive surgery IDE clinical trials designed to improve patient outcome. This includes providing direct patient care services for individuals enrolled in the clinical trials as well as monitoring compliance with Good Clinical Practices (GCP)?the standards for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials?for IDE trials conducted under 21 CFR 81. Duties include patient vision testing, patient consent, providing information to patients in conformance with regulations(21 CFR 50), 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 will include: Conduct and audit clinical examinations to monitor data integrity and compliance with GCP, applicable government regulations and IRB requirements. Obtain informed consent from patients for participation in clinical trials. This includes extensive counseling patients as the risks and benefits of their involvement. Assist in the preparation and execution of Cooperative Research and Development Agreements (CRADAs) and Memos of Understanding (MOUs). Assist in the preparation of technical abstracts and PowerPoint presentations. Assist in the preparation of protocols, IRB submission, case report forms, and subject consent documents. Liaison with FDA on protocol and reporting requirements. IDE preparation, submission, and reports. Provide guidance and support of clinical operations and patient education / testing procedures. The contractor may be required to travel up to 16 times a year. SPECIAL REQUIREMENTS Must have BS in life sciences from an accredited university. Must have at least 5 years of ophthalmic experience with direct patient care and be able to actively participate as an investigator, including creation and presentation of consent materials and performance of visual testing. Must be willing and able to assist patient care services and provide educational information related to the diagnostic testing and visual performance protocols for laser refractive surgery procedures. Must have prior management experience, including creation of clinical procedures and patient instruction materials. Must have prior management experience, including creation of clinical procedures and patient instruction materials. Must have at least 15 years experience in the conduct and 10 years experience in the management of ophthalmic device clinical trials in conformance with FDA requirements and Good Clinical Practices. Must be an active member of the ACRP (Association of Clinical Research Professionals) and RAPS (Regulatory Affairs Professional Society). Must have at least 5 years experience working with a major laser refractive surgery company and at least 3 years experience as a Director of Clinical/Regulatory Affairs in Class II/III ophthalmic devices. Must have experience with the development of Memos of Understanding (MOUs), with other military services. Must have current experience as an associate investigator in at least 2 IDE clinical trials conducted through a DoD medical treatment facility. Must have been involved in the creation and execution of at least three Cooperative Research and Development Agreements (CRADA) between a DoD facility and industry. Must have demonstrated success with ?Significant Risk? IDE trials to include direct experience interfacing with FDA/Opthalmic Devices and division of Bioresearch Monitoring. Must be familiar with the principles of laser refractive surgery methods and wavefront technology, including current research and treatment issues. Must have strong experience writing protocols, consent forms, development of clinical database requirements, preparing data collection methods, initiating and monitoring clinical trials, designing training materials, writing interim and annual reports, planning and conducting investigator meetings, and interfacing with IRBs. Must be able to communicate effectively, orally and in writing using universal English. Must be proficient with computers and familiar with visual testing equipment and software for word processing, clinical data analysis and presentations, specifically Microsoft Office (Word, Excel, and PowerPoint). The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-15. This acquisition incorporates the following FAR clauses: 52.212-1 Instruction to Offers- Commercial Item (Oct95): 52.212-3 Offeror representations and certification ? Commercial Items (Oct95) must be completed and submitted along with the quote (Please contact Laura Pruett at (619) 532-8076), e-mail lmpruett@nmcsd.med.navy.mil, if a copy is needed; in accordance with 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items (Aug96) the following clauses are incorporated by reference in paragraph (a) 52.233-3 Protest after Award (31 U.S.C. 3533) paragraph (b): 52.222-21 Prohibition of Segregated Facilities (Feb 1999), 52.222-26 Equal Opportunity (E.O.11246); 52.222-35 Affirmative Action for Special Disabled and Vietnam ERA Veteran (28U.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 (OST 95). 52.232-33 Payment by ElectronicFunds Transfer-Central Contractor Registration (31 U.S.C. 3332). 52-232-7003 Electronic Submission of Payment Requests (Mar 2003), 52.237-2 Protection of Government Buildings, Equipment, and Vegetation, 52.237-7 Indemnification and Medical Liability Insurance (Jan 1997), 52.252-2, Clauses Incorporated by References (Feb 1998) DFARS 252.204-7004, Required central contractor Registration (MAR 1989); DFARS 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Order Applicable to Defense Acquisitions of Commercial Item (APR2003). 52.212-2, Evaluation ? Commercial Items (1999), 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 it has more importance than 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 quote. All responsible sources may submit a quote which shall be considered. All interested Bidders must submit quotation plus product specification to Laura Pruett, Naval Medical Center San Diego, Material Management Dept., Acquisitions Division, 34800 Bob Wilson Drive, San Diego, CA 92134, or by FAX (619) 532-5596 or by e-mail @ lmpruett@nmcas.med.navy.mil. This solicitation is restricted to small business. All quotation must be received by September 10, 2003, @ 3:30 p.m. Pacific Standard time. (Bids may be MOBIS or GSA Federal Supply Schedule Contract if applicable).
- Place of Performance
- Address: Branch Medical Clinic, Naval Training Center, Refractive Surgery Center, Bldg. 624-3, 2650 Stockton Road, San Diego, CA, ,
- Zip Code: 92106
- Country: USA
- Zip Code: 92106
- Record
- SN00416323-W 20030831/030829213911 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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