PRESOL | A | Clinical Research Associate (Ophthalmic Study Coordinator)

FBO DAILY ISSUE OF JULY 28, 2012 FBO #3899
SOLICITATION NOTICE

A -- Clinical Research Associate (Ophthalmic Study Coordinator)

Notice Date: 7/26/2012
Notice Type: Combined Synopsis/Solicitation
NAICS: 541711 — Research and Development in Biotechnology
Contracting Office: N00259 NAVAL MEDICAL CENTER SAN DIEGO MATERIAL MANAGEMENT 34800 Bob Wilson Drive San Diego, CA
ZIP Code: 00000
Solicitation Number: N0025912T0836
Response Due: 8/8/2012
Archive Date: 9/14/2012
Point of Contact: Lauren Rasmussen 619-532-7643
E-Mail Address: lauren.rasmussen@med.navy.mil
(lauren.rasmussen@med.navy.mil)
Small Business Set-Aside: Total Small Business
Description: NOTICE TO CONTRACTOR This is a COMBINED SYNOPSIS/SOLICITATION for service prepared in accordance with the format in 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 or paper copies of this solicitation will not be issued or available. This Request for Quotation (RFQ), number N00259-12-T-0836, is issued as a Total Small Business Set-Aside in accordance with FAR Subpart 19.502-2, with the intent to award on a competitive basis. Quotations from other than small business concerns will NOT be considered. The closing date is 08 August 2012, 1100 Pacific Standard Time. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-58. It is the contractor ™s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: www.acq.osd.mil/dpap/dars/dfars/index; www.acquisition.gov. The North American Industry Classification System (NAICS) Code for this acquisition is 541711; Size standard: 500 employees. The Naval Medical Center San Diego requests responses from qualified sources capable of providing the following items: CLIN 0001, Clinical Research Associate (Ophthalmic Study Coordinator) QTY: 1920, Unit of Issue: HR, Price: $____________ Anticipated Period of Performance: 01 SEP 2012 “ 31 AUG 2013 Section C - Descriptions and Specifications PERFORMANCE WORK STATEMENT Performance Based Service Acquisition for Clinical Research Associate (CRA) services Directorate for Surgical Services (DSS) Ophthalmology Department Naval Medical Center San Diego (NMCSD) Branch Medical Clinic, Naval Training Center (NTC) 1.0. SCOPE: The Contractor shall provide services of a Clinical Research Associate (Ophthalmic Study Coordinator) to support various research projects at the Navy Refractive Surgery Center for the Ophthalmology Department, Directorate for Surgical Services (DSS) at Naval Medical Center San Diego (NMCSD) Branch Medical Clinic, Naval Training Center (NTC), 2051 Cushing Road, San Diego, CA 92106. A secondary work location is Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134-5000. The mission of the Navy Refractive Surgery Center is to provide state-of-the-art surgical vision correction to active duty Navy and Marine Corps personnel, with emphasis on visual performance enhancement for the war fighter. In addition to clinical services, the center also conducts research to evaluate new technologies in surgical vision correction and other vision sciences. 2.0. GUIDELINES, REGULATIONS AND RESOURCES -Human Subjects Research Guidelines, Regulations and Other Resources Link to webpage 2.1. ACRONYMS AND ABBREVIATIONS: CFTEContractor Full Time Equivalent CID CORClinical Investigations Department Contracting Officer Representative DSS HIPAADirectorate for Surgical Services Health Insurance Portability and Accountability Act IRB KOInstitutional Review Board Contracting Officer OHRPOffice for Human Research Protections POPPeriod of Performance 3.0. REQUIREMENT: The mission of the Naval Medical Center San Diego (NMCSD) is to prepare to deploy in support of operational forces, to deliver quality health services, and to shape the future of military through education, training, and research. In order to optimize the performance in support of accomplishing its mission, NMCSD Ophthalmology ™s Refractive Surgery Center requires the services of a Clinical Research Associate (Ophthalmic Study Coordinator) to support various research projects. 3.1. CLINICAL RESEARCH ASSOCIATE (STUDY COORDINATOR) PROTOCOL COORDINATION DUTIES. 3.1.1. Assist in the creation, development, and maintenance of databases for previous, current, and upcoming research projects. 3.1.2. Enter and track research data in computer databases and study worksheets, records, and reports. 3.1.3. Manage computer entry of research data generated by clinical staff. 3.1.4. Serve as primary contact for data entry issues for multiple clinical studies. 3.1.5. Review subject records for accuracy and completeness for each clinical visit, and identify and resolve any discrepancies/inconsistencies. 3.1.6. Review and update study-related datasets and documents for accuracy and completeness, and identify and resolve any discrepancies/inconsistencies. 3.1.7. Review, incorporate/create, and maintain data entry processes and instructions based on individual research protocols. 3.1.8. Organize and store medical records, worksheets, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and other study data forms; archive study data at study completion. 3.1.9. Schedule study patients, ensuring that appointments fall within FDA window requirements for the study in which they are participating. 3.1.10. Assure FDA regulatory compliance for FDA sponsored studies. 3.1.11. Provide assistance in conducting visual performance tests in a variety of settings to include visual acuity and contrast sensitivity, Carrier Landing and Night Driving Simulators, Wave-front aberration measurements, and other testing as required by research protocols 3.1.12. Aid in the statistical analysis of data, prepare tables and graphs of results, and participate in manuscript preparation. 3.1.13. Act as liaison with study auditors, regulators, collaborators, and sponsors in the management of previous, current, and upcoming clinical studies. 3.1.14. Act as liaison with the IRB for initial and periodic reviews and audits of clinical studies. 3.1.15. Coordinate and interact with Refractive Surgery Center technicians, doctors, scientists, and research personnel to identify priorities and timelines, maximize clinical/research efficiency, and ensure compliance with study and regulatory policies. 4.0. SPECIFIC QUALIFICATIONS AND OTHER REQUIREMENTS. 4.1. SPECIFIC QUALIFICATIONS FOR THE CLINICAL RESEARCH ASSOCIATE (OPHTHALMIC STUDY COORDINATOR). Each contract worker shall meet and maintain the qualifications specified below. The following specific qualifications are additional to the general qualifications given in Section C of the Base contract. 4.1.1. Possess a Bachelors of Science degree from an accredited university in a scientific major (e.g. Biology, Chemistry, or Health Sciences). 4.1.2. Minimum of four years experience in ophthalmic/vision research experience and have knowledge of the mission needs of a refractive surgery research program. 4.1.3. Minimum of two years experience in assuring FDA regulatory compliance for studies. 4.1.4. Basic knowledge of Windows-based computer systems and applications to include Microsoft Word, Excel, PowerPoint, Access, and Outlook email. 4.1.5. Must read, write, speak, and understand the English language fluently and maintain good communication skills with patients and other health care personnel. 4.1.6. Possess sufficient initiative, interpersonal relationship skills and social sensitivity such that they can relate constructively to a variety of patients and staff from diverse backgrounds. 4.1.7. Excellent time management and communication skills; ability to work in a team environment and concurrently support several active clinical research projects. 4.1.8. Two letters of reference written within the past six months attesting to the contract worker's experience in an ophthalmic/vision research setting. Letters must be from practicing eye care professionals (ophthalmologists/optometrists), scientists, professors, and/or research managers. Letters must include the name, title, and telephone number, date of reference, address and signature of the individual providing the reference. 4.2. OTHER REQUIREMENTS 4.2.1. The Contractor shall submit a qualifications package (copy of educational and professional licenses and certifications; an occupational health survey completed within the last six months; proof of U.S. citizenship; two letters of reference; and proof of initiated security background investigation via NMCSD ™s Security Manager ™s Office) to the COR for each contract worker at least 15 days prior to commencement of services. Prior to contractor employees providing services under the contract, the COR will verify the compliance of each contract worker with the qualification requirements contained herein. 4.2.2. Maintain annual occupation health readiness and screening in accordance with NMCSD occupational guidelines. 4.2.3. Maintain current training requirements as required by NMCSD (e.g. HIPAA, Information Assurance) 4.2.4. Upon start, all contract workers will complete NMCSD ™s contractor check-in process via the COR Office. (Note: Original proof of U.S. citizenship required at time of check-in). 4.3. CONTRACT WORKER BACKGROUND INVESTIGATION REQUIREMENTS. 4.3.1. In order to carry out the duties required by the contract, all contract workers will be required to access Navy information technology networks/systems containing sensitive information. Only contract works who are U.S. citizens can be granted access to Department of Navy (DON) Information Technology networks/systems and sensitive information. 4.3.2. Personnel background investigations must be initiated and an advance fingerprint and National Agency Check with Local Credit Checks (NACLC) results received by the MTF prior to a Common Access Card (CAC) being issued to the contract workers. 4.3.3. To obtain a favorable determination, each contractor employee must have a favorably completed National Agency Check with Local Credit Checks (NACLC) which consists of a National Agency Check with Written Inquiries (NACI) including a FBI fingerprint check plus credit and law enforcement checks. Each contractor employee is required to complete:.SF-86 Questionnaire for National Security Positions (or equivalent OPM investigative product).Two FD-258 Applicant Fingerprint Cards.Original Signed Release Statements Failure to provide the required documentation within 30 days prior to the individual's start date may result in delaying the individual's start date. To maintain continuing authorization for an employee to access Privacy Act information on a DoD unclassified computer/network, the contractor shall ensure that the individual employee has and maintains a current requisite background investigation throughout the contract performance period. INTERIM ACCESS The Navy Command's Security Manager may authorize issuance of a CAC card and interim access to a DoN or DoD unclassified computer/network upon a favorable review of the SF-86 questionnaire and advance fingerprint results. When the results of the investigation are received and a favorable determination is not made, contractor employees working on the contract under interim access shall be removed immediately and will no longer be authorized to work on the contract. DENIAL OF ACCESS The potential consequences of any requirements under this clause including denial of physical or system access in no way relieves the contractor from the requirement to execute performance under the contract within the timeframes specified in the contract. Contractors shall plan ahead in processing their employees and subcontractor employees. The contractor shall insert this clause in all subcontracts when the subcontractor is permitted to have physical access to a federally controlled facility and/or access to a federally-controlled information system/network and/or access to government information. 5.0. QUALITY. 5.1. Quality Control: The contractor shall develop and maintain an effective Quality Control Program (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor ™s QCP is the means by which it assures that the work complies with the requirements of the contract. The QCP shall be delivered within 30 days after contract award. Any changes to the QCP shall be submitted to the KO and COR within 5 working days after changes are made. After acceptance of the QCP the contractor shall receive the KO ™s acceptance in writing of any proposed change to the QCP. 5.2. Quality Assurance: The Government shall evaluate the contractor ™s performance under the subsequent task order in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to verify that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied and the frequency of surveillance. 5.2.1. Objective. This QASP serves as the principal basis for assessing overall performance quality by the contractor. This document will be used by the Government to assess the effectiveness of the Contractor ™s performance. This QASP provides the methodology by which the Contractor's performance will be monitored to determine compliance with established performance objectives and to establish performance benchmarks that ensure a quantifiable basis for measuring effectiveness. The plan is designed so that surveillance is limited to that which is necessary to verify the contractor is performing satisfactorily and relates directly to the performance objectives delineated in the Performance Work Statement. 5.2.2. Deliverables. Number of subjects tested in Vision Performance Simulator Final data report for Aircraft Carrier Landing Simulator Study 5.2.3. Performance Requirements Summary Table (PRST). PWS REQUIREMENTPERFORMANCE INDICATOR/ACCEPTABLE LEVEL OF PERFORMANCE (ALP)METHOD OF SURVEILLANCE (MOS)ACCEPTABLE QUALITY LEVEL (AQL) 3.1. Clinical Research Protocol Coordination. Contractor ™s technical performance meets all contract requirements. 100% Inspections Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner. Acceptable Performance and deliverables meet all contract requirements. Performance delivered with minimal to no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner. Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner. 4.1. Specific qualifications for the CRA labor category. Contractor ™s technical performance meets all contract requirements. 100% Inspections Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner. Acceptable Performance and deliverables meet all contract requirements. Performance delivered with minimal to no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner. Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner. 5.2.2. Deliverables Contractor ™s deliverables meet all contract requirements. 100% Inspections Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance/rework; problems that are encountered are minor and resolved in a highly effective manner. Acceptable Performance and deliverables meet all contract requirements. Performance delivered with minimal to no performance/rework; problems that are encountered are minor and resolved in a satisfactory manner. Unacceptable Many contract requirements not met. Re-performances or reworks required. Substantial problems were encountered and were resolved in a less than satisfactory manner. 6.0. PLACE OF PERFORMANCE/WORK HOURS. 6.1. The main place of performance will be at Branch Medical Clinic, Naval Training Center (NTC), 2051 Cushing Road, San Diego, CA 92106. 6.2. Working hours for CRA Ophthalmic Study Coordinator are generally between the hours of 0700 and 1700 (not to exceed 40 hours per week) Monday through Friday. Services are not required on the day of observance of Federal Holidays. 6.3 Contractor Full Time Equivalents (CFTEs). The following are NMCSD ™s desired CFTE allocations for ongoing and future research projects: DEPARTMENTOn-site Hours CFTEs Ophthalmology, NTC 19201.0 There is no wage determination issued for this procurement. In accordance with Title 29 CFR Part 4, Section 4.6(d), the contractor is required to pay no less than the Federal minimum wage. The following FAR/DFARS provisions and clauses are applicable to this procurement: 52.204-7 Central Contractor Registration (FEB 2012) 52.204-9 Personal Identity Verification of Contractor Personnel (JAN 2011) 52.212-1 Instruction to Offerors-Commercial Item (FEB 2012) 52.212-2 Evaluation Commercial Items (JAN 1999) Evaluation factors in descending order of importance: 1) Technical Capability, 2) Past Performance and 3) Price 52.212-3 Offeror Representations and Certification--Commercial Items (MAR 2012) 52.212-4 Contract Terms and Conditions--Commercial Items (FEB 2012) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (MAR 2012) with the following clauses incorporated by reference: 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (FEB 2012), 52.219-6 Notice of Total Small Business Set-Aside (NOV 2011), 52.219-28 Post Award Small Business Program Representation (APR 2009), 52.222-3 Convict Labor (JUN 2003), 52.222-19 Child Labor -- Cooperation with Authorities and Remedies (MAR 2012), 52.222-21 Prohibition of Segregated Facilities (FEB 1999), 52.222-26 Equal Opportunity (MAR 2007), 52.222-36 Affirmative Action for Workers with Disabilities (OCT 2010), 52.222-41 Service Contract Act of 1965 (NOV 2007), 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011), 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008), 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003) 52.217-8 Option to Extend Services (NOV 1999) 52.219-1 Alt I Small Business Concern Program Representation (APR 2011) 52.224-1 Privacy Act Notification (APR 1984) 52.224-2 Privacy Act (APR 1984) 52.237-7 Indemnification and Medical Liability Insurance (JAN 1997) 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) www.acquisition.gov; www.acq.osd.mil 52.252-2 Clauses Incorporated By Reference (FEB 1998) www.acquisition.gov; www.acq.osd.mil 252.201-7000 Contracting Officer ™s Representative (DEC 1991) 252.204-7004 Alternate A, Central Contractor Registration (SEP 2007) 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (MAR 2012) with the following clauses incorporated by reference: 252.225-7001 Buy American Act and Balance of Payments Program (JUN 2012), 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports (MAR 2008). 252.225-7002 Qualifying Country Sources As Subcontractors (APR 2003) NAVY COMMERCIAL ACCESS CONTROL SYSTEM (NCACS) PROGRAM IMPLEMENTATION INSTRUCTION (August 2011) (a) In accordance with CNICNOTE 5530 dated May 2, 2011, NCACS credentialing should be established in order to avoid unnecessary delay at military installation entry control points (ECP). (b) NCACS guidance for Vendors/Contractors to obtain a pass is accessible through the following website: http://cnic.navy.mil/CNIC_HQ_Site/index.htm, popular links. For more information or to enroll in the NCACS Program call: 1.877.727.4342. For Naval Base San Diego Pass and Decal Office, call: 1.619.556.1653 (c) Vendors, contractors, suppliers and other service providers shall present their pass upon entry at ECP. NECO Electronic Posting to NECO (DEC 2005) INFORMATION ONLY: This document has been designated for posting to the Navy Electronic Commerce Online (NECO) at http://www.neco.navy.mil The Government intends to award a firm, fixed price contract resulting from this combined synopsis/solicitation to the responsive and responsible offeror whose conforming response is determined to provide the best value to the Government, price and other factors considered. The following factors to be used to evaluate offers: 1.Technical Capability. Defined as, an assessment of the prospective contractors key management personnel to determine if they have the basic knowledge, experience, and understanding of the requirements necessary to provide the requested items. 2.Past Performance. Provide three (3) references, addressing that you have provided the same or similar items in the last 3 years. 3.Price. Technical capability and past performance, when combined, are significant evaluation factors that will be used to arrive at a best value award decision. Contractors who do not meet the first 2 factors will not undergo a price evaluation. The Government will only consider firm fixed-price quotations. Offeror must complete and submit with the quotation FAR provision 52.212-3 Offeror Representations and Certifications-Commercial Items (MAR 2012) Offeror must be registered to the Central Contractor Registration (CCR) prior to award. The website address is www.ccr.gov. A Data Universal Number System (DUNS) number is required to register. Email your quote to Lauren Rasmussen on or before 1100 Pacific Standard Time on 08 August 2012 to be considered responsive. Email: Lauren.Rasmussen@med.navy.mil Submitter should confirm receipt of email submissions. All quotes shall include price(s), FOB point, a point of contact, name and phone number, GSA contract number if applicable, business size, and payment terms. Quotes over 12 pages in total will not be accepted (including solicitation). Each response must clearly indicate the capability of the quoter to meet all specifications and requirements. Deadline for requesting clarification and submitting any relevant questions is 02 August 2012, 0800 Pacific Standard Time.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N00259/N0025912T0836/listing.html)
Place of Performance: Address: 2051 Cushing Road, San Diego, CA; Zip Code: 92106
Record: SN02816978-W 20120728/120727000703-54900002a72cf79286400e56759b3c5a (fbodaily.com)
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A -- Clinical Research Associate (Ophthalmic Study Coordinator)