SOLICITATION NOTICE
A -- CLINICAL RESEARCH ASSOCIATE
- Notice Date
- 8/9/2011
- 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
- N0025911T0362
- Response Due
- 8/19/2011
- Archive Date
- 9/30/2011
- Point of Contact
- Rey de Vera 619-532-5564
- Small Business Set-Aside
- N/A
- Description
- This is a combined solicitation/synopsis 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, N00259-11-T-0362 is issued as a request for quotation (RFQ). The North American Industry Classification System (NAICS) Code for this acquisition is 541711; Size: 500. All interested bidders shall submit quotations electronically by email to reynaldo.devera@med.navy.mil or by facsimile at 619-532-5596, attention Rey de Vera. E-mail submissions are limited to 2MB. The submitter should confirm receipt of facsimile and email submissions. Quotations are due on or before 19 August 2011, 04:00PM Pacific Standard Time to be considered responsive. CLIN 0001 Non Personal Services for Clinical Research Associate QTY 12 Mo $________per month Period of Performance: 01 September 2011 through 31 August 2012 Contractor must be registered to the Central Contractor Registration (CCR) prior to award. The website address for CCR registration is www.ccr.gov Contractor MUST complete FAR 52.212-3, Offeror Representations and Certifications Commercial Items, when submitting a proposal. The website address is http://www.acquisition.gov. DELIVERY ADDRESS: Branch Medical Clinic, NTC, Navy Refractive Surgery Center, 2051 Cushing Road, San Diego, CA 92106 The solicitation document and incorporated provisions and clauses are those in effect through FAC 2005-50 and DFARS Change Notice 20110304. This acquisition incorporates the following FAR clauses: 52.204-7 Central Contractor Registration (APR 2008) 52.212-1 Instruction to Offerors-Commercial Item (JUN 2008) 52.212-2 Evaluation-Commercial Items (JAN 1999) 52.212-3 Offeror Representations and Certification--Commercial Items (MAY 2011) 52.212-4 Contract Terms and Conditions--Commercial Items (JUN 2010) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (MAY 2011) 52.219-28 Post Award Small Business Program Representative (APR 2009) 52.222-3 Convict Labor (JUN 2003) 52.222-19 Child Labor -- Cooperation with Authorities and Remedies (JUL 2010) 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) 52.223-18 Contractor Policy to Ban Text Messaging while Driving (SEP 2010) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003) 52.252-2 Clauses Incorporated By Reference (FEB 1998) 252.204-7003 Control of Government Personnel Work Product (APR1992) 252.204-7004 Alt A Central Contractor Registration (52.204-7) Alt A (SEP 2007) 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (APR 2007) 252.225-7001 Buy American Act and Balance of Payment Program (JAN 2009) 252.225-7002 Qualifying Country Sources As Subcontractors (APR 2003) 252.232-7003 Electronic Submission of Payment Requests (MAR 2008) All responsible sources may submit a quotation which shall be considered by the agency. Performance Work Statement (PWS) Part 1: Description of Services Part 2: Performance Requirement Summary Table (PRST) Part 3: Government Furnished Facility/Property Part 4: General Information Attachment 0001- Personal Qualifications Sheet- Clinical research Associate- Level I (CRA I) Attachment 0002- US Citizenship Requirements (Employment Eligibility) Attachment 0003- Privacy and Security of Protected Health Information Attachment 0004- Contract Data requirements List (DD 1423) Part 1 Description of Services Clinical Research Associate Level I (CRA I) Patient Reported Outcomes with LASIK (PROWL-1) Study Navy Refractive Surgery Center (NRSC), Naval Medical Center San Diego 1. Introduction. The contractor shall perform work as described in the Performance Work Statement (PWS) and shall consider the following: This performance based work statement specifies the analytical functions required to develop and validate objective methods and metrics for evaluating Quality of Vision (QoV) for aviators before and after refractive surgery. This requirement is to provide off-site research services in support of the Refractive Surgery Center, Naval Medical Center San Diego. This contract will be evaluated using performance management techniques and insight of Contractor performance rather than strict oversight. The ability to make decisions based on performance data analysis is the cornerstone of performance management. The Performance Work Statement (PWS), Performance Requirement Summary Table (PRST), and Contractor developed metrics shall focus on desired outcomes and not interim process steps. Interim process metrics are delegated to the Contractor who shall manage the processes and practices used to achieve contract outcomes by a Contractor Quality Control Plan. Using an outcome focus provides the Contractor with the flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are achieved at the specified intervals. Contracting has been chosen as a strategy to permit expansion of the capacity of DOD facilities by overcoming shortfalls in the numbers of support personnel. The services rendered by the Contractor are rendered in the capacity of an independent Contractor. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the Commander, Naval Medical Center San Diego maintains administrative and operational responsibility for all activities within the Medical Treatment Facility (MTF) and may take such actions as necessary to preserve and maintain the integrity of the MTF, subject to the limitations prescribed by law and U.S. Navy Regulations. 1.1. Performance Work Statement (PWS) This non-personal service contract is a true performance based contract in that: (i) States in the Performance Requirements Summary Table (Attachment 01) what needs to be done. (ii) The Performance Standards specify the outcomes and deliverables expected for and from these services; and (iii) the Measurement Technique in the Quality Assurance Surveillance Plan (QASP) states how performance will be assessed. 1.1.1. Scope of Work. The Contractor shall provide a Clinical Research Associate-Level I (CRA I) who will function independently as Study Coordinator for the Patient Reported Outcomes with LASIK (PROWL-1) study; a collaborative protocol of the U.S. Navy, Food and Drug Administration (FDA) and the National Institutes for Health (NIH). 1.1.2. Hours of Services. The contractor shall perform contracted services duties on-site, at the Navy Refractive Surgery Center (NRSC) San Diego located at the Branch Health Clinic (BHC) NTC San Diego, and the Ophthalmology Department, located at the Naval Medical Center San Diego. The Refractive Surgery Center s normal clinic hours are Monday Friday from 0700 to 1630. The Ophthalmology Department s normal clinic hours are Monday Friday from 0700 to 1630. Contracted services are not required on observed Federal holidays. 1.2. Functions to be performed: 1.2.1. Serve as point of contact and subject matter expert for all questions and issues pertaining to the PROWL-1 study Protocol and ensure compliance with protocol requirements. 1.2.2. Independently interview and inform prospective subjects about the PROWL-1 study at the Navy Refractive Surgery Center. 1.2.3. Obtain fully informed consent for Navy Refractive Surgery Center from subjects enrolling in the PROWL-1 study. 1.2.4. Collect, enter and track PROWL-1 study research data in various electronic and hardcopy databases in accordance with approved protocol. 1.2.5. Review and update PROWL-1 study records, study-related datasets, and other documents for accuracy and completeness, and identify and resolve any discrepancies/inconsistencies. 1.2.6. Contact PROWL-1 study patients to ensure completion of their required study questionnaires and examinations. 1.2.7. Organize and Maintain PROWL-1 study informed consents in accordance with protocol approved by the NMCSD Institutional Review Board (IRB) and research standards. 1.2.8. Organize PROWL-1 study research binders and documents as required by the NMCSD IRB and the FDA. 1.2.9. Organize and store medical records, worksheets, Case Report Forms (CRFs), Data Clarification Forms (DCFs), and other PROWL-1 study data forms. 1.2.10. Drawing from the organized data provided by the Research Associate, assist the Principal Investigator in preparing and presenting Annual Reviews for the PROWL-1 study. 1.2.11. PPreparePROWl-1 study data for FDA site visits to Navy Refractive Surgery Center (NRSC) and/or the Ophthalmology Department, Naval Medical Center San Diego (NMCSD). 1.2.12. Perform statistical analyses in support of the PROWL-1 Study, preparing tables, graphs, charts that present study findings in concise format. This analysis will be used for presentations to the FDA and other professional organizations. 1.2.13. Assist the Principal Investigator with the preparation of PROWL-1 study manuscripts, ensuring the analyses of data are consistent with the manuscript content. 1.2.14. Coordinate and interact with Navy Refractive Surgery Center technicians, doctors, scientists, and research personnel to identify PROWL-1 study priorities and timelines, maximize research efficiency, and ensure compliance with regulatory policies. 1.3. Contractor Quality Control (QC) 1.3.1. Provide Qualified Personnel. The Contractor and all Contractor personnel shall possess all licenses, permits, training, certifications required to perform the contract requirements. The Contractor shall provide curriculum vitae of all personnel proposed under this Contract. The individuals training and qualifications shall meet all contract requirements for the position in which they are working. Personnel Qualifications are listed under Part 1, Item 1.8.2; and in Attachment 0001 (Personal Qualifications Sheet- Clinical Research Associate-Level I). 1.3.2. Quality of Services. The services specified in this work statement shall be performed in accordance with established principles and ethics of the clinical research profession. The Contractor shall comply with applicable provisions of law and the rules and regulations of all Governmental authorities. 1.3.3. The Contractor shall adhere to and comply with all Department of Navy (DON), Bureau of Medicine and Surgery (BUMED) and MTF Instructions and notices, which may be in effect during the term of the contract. To achieve these goals, the Contractor shall establish, submit for Government approval and implement a Quality Control (QC) Program, which is compatible with the MTF Quality Control Program. 1.3.4. The Contractor shall maintain a copy of this contract, and a current Contractor QC Program at all times. Contract employees shall read, be familiar with, and implement the contract, including the technical proposal, Quality Control Program, and any revisions thereto. 1.3.5. Outline of Responsibilities: The contractor shall establish a Quality Program that encompasses all aspects of the contract. Ensure that timely and effective corrective actions are obtained for all deficiencies identified by the Program and the Government. The Government will remotely evaluate the contractor s performance under this contract. When an observation indicates defective performance, the COR will inform the contractor. All deficiency responses shall include identification of the cause of the deficiency to preclude recurrence and an analysis of the quality program s effectiveness in the area of the deficiency. Develop and maintain a training program designed to ensure all contractor personnel are clearly aware of the contractual requirements and are current from the time of contract start and remain current on any changes throughout the life of the contract. Inspection, auditing, and testing shall be prescribed by clear, complete, and current instructions. The inspection instructions shall include the specific criteria for approval and rejection of services that shall be used in each inspection or audit. Checklists may be used for this purpose. The Contractor's inspection instructions shall be documented and shall be available for review, by the COR or KO, throughout the life of the contract. The Contractor shall notify the COR in writing of any changes to Contractors inspection instructions. Conduct special item inspections at the KO/COR, MTF Commander or designated representative s written request. Results of the inspection or audit shall be provided, in writing, in a timely manner. 1.3.5.1. The Quality Control inspection system shall satisfy the requirements in the Inspection Clause and the Performance Requirement Summary Table (PRST) of the Contract. It shall be designed to keep the Contractor informed of all issues affecting quality. The records of inspections shall indicate the nature and number of observations made; the number and type of deficiencies found and the nature of corrective action taken as appropriate. Records will be available to the COR and shall be maintained during the contract life. 1.3.5.2. Quality Control Matrices/Technical Progress Reports: the Contractor shall electronically submit via email to the Contracting Officer and COR, each 30-day period during the life of this contract, a copy of QC matrices for each PRST item. Metrics must verify whether the performance standards in the PRST have been met. The Contractor shall also provide via email, technical reports describing progress of the program to date, noting all technical areas in which effort is being directed and indicating the status of work within these areas. These emailed reports shall also be available to the COR and shall include as a minimum: 1.3.5.2.1. A quantitative description of overall progress and applicable supporting data, as necessary, and in sufficient detail to comprehensively explain progress to date. 1.3.5.2.2. An indication of any current problems which may impede performance, and proposed corrective action, and 1.3.5.2.3. A discussion of the work to be performed during the next reporting period. 1.3.5.3. A monthly narrative report shall be provided to the COR via e-mail. The reports shall be delivered not later than five calendar days after the end of the month being reported. 1.4. Safety Program and Safety Training 1.4.1. Outline of Responsibilities: The contractor shall follow a plan that meets the Naval Medical Center San Diego safety program standards. The plan will be a part of the Contractors Quality Control Plan and also address Material Safety Data Sheet use for required items when introduced to NMCSD facility. The contractor shall submit a copy of the safety plan to the Contracting Officer (KO) for approval and one copy to the COR prior to performance start. The plan will be updated as changes are made. Government shall furnish safety training that is specific to working at NMCSD. 1.4.2. Accident/Injury Incident Reports: All accidents which may arise out of or in connection with the performance of services required herein, and which result in injury, death or property damage, shall be reported immediately to the Safety Department and the COR and within 24 hours to the MTF QI Department. Verbal reports shall be followed up in writing within 24 hours. Statements of witnesses shall be included. If any claim is made by a third party against the Contractor on account of any accident which occurs in connection with the performance of this contract, the Contractor shall promptly report the facts in writing to the MTF Legal Advisor, the MTF QI Department, MTF Safety Department, and the COR 1.5. OCCUPATIONAL HEALTH 1.5.1. Within 30 days prior to performance of services, the contract worker shall obtain, at contractor expense, documentation of required immunizations and physical testing, and a statement from the contract worker s physician or a report of a physical examination. The physical examination and immunization documentation shall indicate that the contract worker is free from mental or physical impairments that would restrict the contract worker from providing the services described herein. The requirements are provided on the HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM, the current version of which is available at: http://www.nmlc.med.navy.mil/handbooks/Physical%20Exam%20and%20Immunization%20Form.pdf. Declinations shall only be permitted based on either the contract worker s religious convictions or medical contraindications (as documented by a qualified health care provider). The Hepatitis B vaccine declination can be found on the World Wide Web at http://www.osha.gov/SLTC/etools/hospital/hazards/bbp/declination.html. 1.5.1.1. Prior to performance of services, during the orientation, the contract worker must provide documentation of required immunizations. A contract worker must receive the first vaccination of his/her initial vaccination series prior to commencing service under the contract and must complete the series not later than 6 months after commencing service and, if a negative titer is obtained, must complete the second series within another 6 months; or 1.5.1.2. A contract worker who has completed his/her initial series and obtained a negative titer must commence his/her second vaccine series prior to commencing service and must complete the second series not later than 6 months after commencing service. 1.5.1.3. A contract worker approved according to the provisions above will be considered persistent non-responders until there is evidence to the contrary and will be counseled by a licensed practitioner regarding the implications of non-response. 1.5.1.4. If the contract worker fails to comply with the applicable schedule above, this contract may be terminated if so directed by the contracting officer. 1.5.1.5. Except as provided in paragraphs 1.5.1.6 and 1.5.1.7 below, or unless the contract worker is otherwise entitled to Government medical services (e.g., an eligible beneficiary), no medical tests or procedures required by the contract may be performed in the MTF. Expenses for all required tests and/or procedures shall be borne by the contractor at no additional expense to the Government. 1.5.1.6. Contract workers shall agree to undergo personal health examinations and such other medical and dental examinations at any time during the term of this contract, as the Commanding Officer may deem necessary for preventive medicine, medical surveillance, performance improvement, or privileging purposes. These examinations will be provided by the Government. If the contractor chooses, these examinations may be provided by private physician or dentist, at no expense to the Government. 1.5.1.7. It is essential that the contract worker be vaccinated annually against influenza according to BUMED and CDC guidelines aimed at reducing the impact of influenza disease in health care settings. The Government will provide the influenza vaccine free of charge. If the contract worker chooses to be immunized by the Government, the contract worker shall sign a waiver releasing the Government from legal liability in accordance with local procedures and policies. Alternately, the contract worker may obtain the vaccine at another facility, with the contract worker bearing the total cost, and provide proof of vaccination to the Government. If the contract worker declines vaccination, a signed declination form shall be provided to the Government in accordance with CDC recommendations and MTF policies. 1.5.1.8. Contract workers who do not show a positive antibody titer after immunization and appear to have a "non-immune" status must report varicella exposure to the COR. In accordance with Centers for Disease Control Recommendations, such contract workers may be removed from patient care duties beginning on the tenth day following exposure and remain away from work for the maximum incubation period of varicella (21 days). The decision to remove a contract worker from patient care will be at the discretion of the Program Director, Internal Medicine. 1.5.1.9. Prior to reporting for service at an MTF, each contract worker shall be screened at contractor expense for risk of exposure to tuberculosis (TB) as part of the Health Examination and Immunization/Screening Requirement Form in 1.5.1. If the contract worker is determined to have a low risk of exposure, no further screening or testing is required under this contract. The initial screening may be waived, at the discretion of the MTF, if the contractor provides evidence of a prior low risk assessment by a licensed physician. If the initial screening results in a determination that the contract worker has an increased risk of exposure to TB, the contractor is responsible for ensuring that the contract worker receives targeted screening and testing in accordance with CDC Guidelines for Health-Care Settings and submitting timely records of subsequent screening or testing to the COR. 1.5.1.10. Except as provided in paragraph 1.5.1.11 below, or unless the contract worker is otherwise entitled to Government medical services (e.g., an eligible beneficiary), no medical tests or procedures required by the contract may be performed in the MTF. Expenses for all required tests and/or procedures shall be borne by the contractor at no additional expense to the Government. 1.5.1.11. Contract workers shall agree to undergo personal health examinations and such other medical and dental examinations at any time during the term of this contract, as the Commanding Officer may deem necessary for preventive medicine, medical surveillance, performance improvement, or privileging purposes. These examinations will be provided by the Government. If the contractor chooses, these examinations may be provided by private physician or dentist, at no expense to the Government. 1.5.1.12. BLOOD BORNE PATHOGEN ORIENTATION PROGRAM. Contract workers shall participate in the Command s Blood Borne Pathogen Orientation Program. The contract employee shall also participate in all required annual training and in periodic training for all procedures that have the potential for occupational exposure to blood borne pathogens. 1.5.1.13. MANAGEMENT OF HIV POSITIVE CONTRACT WORKERS. HIV positive contract workers will be managed in accordance with the current Centers for Disease Control (CDC) guidelines and Section 503 of the Rehabilitation Act (29 U.S.C. Section 793) and its implementing regulations (41 CFR Part 60-741). 1.5.1.14. PREVENTION OF THE TRANSMISSION OF THE HIV VIRUS. Contract workers shall comply with the CDC s Universal Precautions for the prevention of the transmission of the HIV virus. 1.5.2. The Contractor shall be responsible for compliance with any certification or requirement arising from Federal and State health regulations in the performance of this contract. 1.5.3. The Contractor shall be responsible for all testing and/or treatment for Contractor employees which may result due to an exposure, injury or hazard of the job, except for the initial stabilization. 1.5.4. The Secretary of the Navy has determined that the possession or use of illegal drugs and paraphernalia by contract employees in the 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 detect and deter any and all drug offenses by contract employees on military installations. In an effort to curtail drug offenses on military installations and to prevent introduction of illegal drugs and paraphernalia, the Government reserves the right to conduct routine, random inspections of personal possessions and vehicles on military installations with drug detection dog teams. When the Government finds probable cause to believe that a contract employee on board a Naval or Marine Corps installation has been engaged in the illegal possession, use or trafficking of drugs, the employee may be restricted or detained until he can be removed from the installation or can be turned over to local law enforcement authorities having jurisdiction, as appropriate. When the Government discovers illegal drugs in the course of an inspection of a vehicle operated by a Contractor employee, the employee and vehicle may be detained until the employee and the vehicle can be turned over to appropriate civil law enforcement officials. The Government may take action to suspend, revoke or deny the contract employee's installation driving privileges as well as his/her clinical privileges at the military MTF. Implicit with the acceptance of this contract is the agreement by the Contractor and his employees to comply with all Federal laws and statutes and installation regulations. 1.5.6. The Contractor shall comply with all fire prevention measures prescribed in the installation fire protection regulations which are in or may be put into effect during the course of this contract. Copies of these regulations are on file in the office of the Head, Operating Management Department or with the COR. The Contractor shall be liable for loss of Government property attributed to negligent or willful misconduct of the Contractor or his employees, including failure to comply with the fire prevention measures described in the aforementioned regulations. At the close of operations each day, the Contractor or his designee shall be required to make a thorough inspection in each work area to determine that all necessary safeguards relative to probable fire hazards are in effect. The Contractor shall familiarize his employees with the aforementioned fire regulations, location of fire reporting telephones near work sites, and correct fire reporting procedures. The Contractor and his employees shall be cognizant of and observe all requirements for handling and storing combustible supplies and materials, daily disposal of combustible waste, trash, etc. 1.6. ORIENTATION 1.6.1. INFORMATION TECHNOLOGY/SENSITIVE INFORMATION SECURITY ORIENTATION. Prior to the provision of services, each contract worker granted access to DOD and DON IT systems/networks or DOD and DON sensitive information shall complete 12 hours of Information Technology orientation: On-site application with the Department of Defense (DoD) Contractor Verification System; receipt of DoD Common Access Card, NMCSD ID Badge, DoD Contractor Vehicle Decal, Consultant Parking Permit DoD/DON Email account (3 hours); Web-based DOD Information Assurance Awareness Training (1 Hour), Composite Health Care System (CHCS) Orientation (2 hours) and Armed Forces Health Longitudinal Technology Application (ALHTA) training (6 hours). 1.6.2. COMMAND ORIENTATION. The contract worker shall complete 24 hours of command orientation within 90 days workers after the start of services. 1.7. RESEARCH EQUIPMENT INVENTORY 1.7.1. Prior to the commencement of contractual services, the Contractor shall conduct a joint inventory with the Government of the equipment provided by the Government. The Contractor and the Government shall jointly determine the working order of all equipment. Items not in working order, beyond fair wear and tear, or beyond repair shall be noted. The Contractor and the Government shall certify their agreement with all comments on working order and discrepancies. Although all reasonable effort will be made by the Government to jointly conduct this inventory, if the Contractor does not participate in the inventory, the Contractor shall accept as accurate the listing of equipment provided by the Government. 1.7.2. Throughout the contract period, the Contractor shall maintain a current inventory of equipment. Any equipment determined to be missing, lost, or stolen shall be immediately reported to the NMCSD Security Officer per MTF instruction with a copy of the report to the COR. The Contractor shall cooperate with and assist in the investigation. 1.7.3. The Contractor is liable for loss of or damage to equipment if such loss or damage is due to negligence or willful misuse. 1.7.4. In accordance with NMCSD policies, the Contractor shall initiate a maintenance request when repair or maintenance of Government-furnished equipment or facilities is required. 1.7.5. At no time during the term of this contract shall the Contractor remove Government furnished equipment or supplies from the MTF. 1.8. PERSONNEL QUALIFICATIONS. 1.8.1 General. 1.8.1.1. The Contractor shall ensure that employees providing services under this contract are able to read, write, and speak English fluently in order to effectively communicate with all NRSC staff. 1.8.2. QUALIFICATIONS. Each contract worker shall possess the following minimum qualifications: 1.8.2.1. Bachelor s Degree in a scientific major (e.g., Biology, Chemistry, Health Sciences, etc) from an accredited college or university. 1.8.2.2. A minimum of one year of relevant clinical research experience in coordinating/managing clinical research studies within the preceding 3 years. 1.8.2.3. Proficiency with computers and software for programming, (e.g., MatLab, C++), word processing, graphic productions, database management, and statistical analysis (e.g., Statistica, Minitab, SAS, SPSS). 1.8.2.4. Provide two letters of reference written within the past six months attesting to the contract worker s experience and capability in coordinating/managing clinical researchstudies; and proficiency with computers and software (e.g. for programming, word processing, database management and statistical analysis). The letters must be from practicing ophthalmologists/optometrists, physicists, scientific program managers, or principal investigators who personally observed and evaluated the contract worker s clinical research coordination/management performance and can attest to their analytical and research competence. Letters must include the name, title, and telephone number, date of reference, address and signature of the individual providing the reference. 1.8.2.5. Must be a U.S. Citizen. 1.9. NMCSD PHYSICAL SECURITY: 1.9.1. The Contractor shall safeguard Government property and, at the close of each work day, secure Government facilities and equipment in his/her work area. 1.9.2. The Contractor shall be responsible for ensuring that keys issued by the Government are for the exclusive use and access of contract employees engaged in the performance of this contract. 1.9.3. The Contractor shall ensure that no Government lock combinations are revealed to unauthorized persons. 1.9.4. The Contractor shall be responsible for Government-issued keys which are lost or used by unauthorized individuals. The Contractor may be required to replace, re-key, or reimburse the Government for replacement of locks or re-keying necessitated by Contractor employees losing keys. The Contractor shall not duplicate any Government-issued keys. 1.9.5. Any instances in which Government pro
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