W911QY16R0027_OSIRIS_RFP.docx

W911QY-16-R-0027

Section B - Supplies or Services and Prices

CPFF Labor

CPFF

To include all data requirements as listed in Section J, DD Form 1423.

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

Travel for CPFF Task Orders

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ODCs for CPFF Task Orders

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

FFP Labor

FFP

To include all data requirements as listed in Section J, DD Form 1423.

NET AMT

Travel for FFP Task Orders

NET AMT

ODCs for FFP Task Orders

NET AMT

CTR Manpower Reporting, due the 31st of Oct each year

NET AMT

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

$2,500.00

$32,700,000.00

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

OPERATIONAL SUPPORT AND INVESTIGATIONAL RESEARCH

IN INFECTION AND SEROLOGY (OSIRIS)

(Version 30-MAR-2016)

C.1 BACKGROUND & PURPOSE

Infectious diseases are a constant threat to the readiness of US military forces at home and abroad. Given the dynamic nature of global pathogen transmissibility, diseases that may have once been confined to remote areas of the world are carried to new areas with relative ease. Expeditionary operational forces are especially susceptible due to their exposure to areas/regions of high risk and the potential for rapid, high volume transmission among close quartered personnel. In support of disease risk assessment and prophylactic clinical responses such as vaccine and drug therapeutics, research efforts require active surveillance from worldwide field sites, identification of recurring and emerging diseases, advanced characterization methods, and developing and testing new technologies for pathogenic detection and viral mutagenic prediction. The continued emergence of novel pathogens strengthens the demand for infectious diseases surveillance and research efforts.

The Naval Medical Research Unit No. 3 (NAMRU-3) is the largest U.S. overseas military medical research facility. Based in Cairo, Egypt since 1946, NAMRU-3’s mission is to study, monitor, and detect emerging and re-emerging disease threats of military and public health importance; develop mitigation strategies against these threats in partnership with host nations and international and U.S. agencies in CENTCOM, EUCOM, and AFRICOM areas of responsibility. NAMRU-3 accomplishes its mission through collaboration with US government and academic groups as well as local institutes and ministries. Staff develops and tests vaccines and therapeutic agents, evaluates diagnostic assays and advances vector control measures. NAMRU-3 plays a key role in surveillance of pathogens in its Area of Responsibility (AOR) and in providing outbreak assessment and support mission. NAMRU-3 maintains research programs including the Bacterial and Parasitic Diseases Research Program, Viral and Zoonotic Diseases Research Program, Vector biology Research Program and the CDC-Global Disease Detection and Response Research Program (GDDRP).

The objective of this acquisition is to procure contractor support and travel for basic and clinical research efforts, surveillance, vaccine efficacy, performance and evaluation of new diagnostic capabilities, and research report development conducted in consonance with the mission of NAMRU-3.

C.2 GENERAL REQUIREMENTS

C.2.1 General

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services* necessary to perform under this contract, as defined in this Performance Work Statement except for those items specified as government furnished property and services, if any. The contractor shall perform to the standards in this contract to: 1) provide management between the US Government and potentially foreign personnel located at the client’s site or (AOR); and 2) assist in the design and execution of field and laboratory research related to emerging infectious diseases. The latter may include but not be limited to: (a) collection of samples and specimens under biosurveillance and research protocols (e.g., drawing of blood), (b) collection of mosquitoes (including taxonomy and identification of mosquitoes) for entomology/vector studies, (c) lab analysis of samples and specimens (e.g., molecular analysis of influenza samples), (d) work with primates and small animals (e.g. studies investigating animal-human ‘jumps’ in disease transmission), (e) lab assay development, (f) proposal and protocol writing, (g) clinical testing and lab evaluation of vaccine and therapeutic countermeasures, (h) development and maintenance of data repositories containing information from the aforementioned, (i) performance of epidemiological research using as a basis the aforementioned, and (j) safety maintenance of personnel involved with research (e.g., personnel medical physicals, lab tests, vaccine injections, etc.).

*May include driving US Embassy or NAMRU-3 vehicles off compound, which is allowable and not considered a personal service when performed incidentally due to special circumstances while located OCONUS/Foreign. Driving tasks may include (but are not limited to) driving to field sites for research sample collection, or shuttling passengers for official business on behalf of the command (vice personal errands or requests, which would be considered a personal service). Reference US Department of State Foreign Affairs Manual, Section 14 Part 430, “Managing Official Vehicles at Posts Abroad” and DoD 4500.36-R, “Management, Acquisition, and Use of Motor Vehicles.”

C.2.2 Period of Performance

The Ordering period for this contract shall be for five (5) years, starting on 1 Aug 2016 and ending on 31 Jul 2021. The period of performance for each task order issued shall be of one (1) year duration or less, except for unique instances in which the needs of a specific research study or program require the use of a task order exceeding that limit.

C.2.3 Quality Control

The contractor shall develop and maintain an effective quality control program 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 quality control program (QCP) is the means by which he assures himself that his work complies with the requirement of the contract.

C.2.4 Quality Assurance

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP), Attachment 1 in Section J. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

C.2.5 Phase In/Out Period (As needed)

To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 30-day phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

C.2.6 Individual Task Orders

C.2.6.1 Each Task Order awarded under this contract will have its own PWS to perform some or all of the above noted tasks in the NAMRU-3 AOR. Task Order PWSs will be specific as to descriptions of work to be performed, duration of work to be performed, and location of work to be performed under each Task Order.

C.2.6.2 This contract will accommodate both severable and non-severable Firm-Fixed-Price (FFP) and Cost-Plus-Fixed-Fee (CPFF) type task orders (CPFF being dependent upon the contractor possessing an acceptable accounting system with DCAA-approved indirect rates). Upon ordering, CPFF type task orders will be deemed either completion or term form. The completion form describes the scope of work by stating a definite goal or target and specifying an end product (e.g., a final report of research accomplishing a goal or target) such that completion of the goal, target, or end product is necessary in order for the Government to successfully receive such benefit. The term form describes the scope of work in general terms and obligates the contractor to devote a specified level of effort for a stated period of time. A term or level of effort may have monthly and final reports (as per the CDRLs) but completion of such reports does not prohibit the Government from successfully receiving the benefit. The term form is not a time and material type contract or fixed labor rate contract in this context. In accordance with FAR 52.232-20—Limitation of Cost, for completion-form CPFF task orders, the contractor will be required to notify the Contracting Officer if the total cost for performance will be either greater or substantially less than previously estimated. In the case of the latter, the Contracting Officer may negotiate total fee downward to be commensurate with actual work performed.

C.2.7 Local Staffing Sources

For this contract it is anticipated that a prime contractor will work in conjunction with local solution partners/ subcontractors to ensure that local sourcing is utilized to the fullest, thereby giving NAMRU-3 the most cost effective solution, while maintaining a level acceptable performance. Any prime contractor working in Egypt or in-theater AOR will ensure compliance with all tax and labor laws, including multi-tier taxable income tax rates, Social Insurance Law (such as Social Security) covering Egyptian employees as well as foreign employees whose countries have treaties with Egypt for reciprocal social insurance treatment, employer compliance obligations as defined under Egyptian law, work permit/visa requirements, indirect taxes, compliance with business registration laws, and local taxes including double taxation. Same applies to other countries where comparable and applicable. (There is no threshold/minimum number of days that exempts the employee from the requirements to file and pay tax in Egypt.) There is also compliance with the cognizant US command of the relevant regions and the US State Department, as there is high risk when entering into the area.

C.3 SCIENTIFIC/TECHNICAL SERVICES REQUIREMENT

The purpose of this acquisition is to provide scientific/technical (including administrative) services in support of medical research and development for NAMRU-3 that are not personal services, inherently governmental functions, or subject to OMB Circular A76. Support is needed for the following specific requirement topic areas:

C.3.1 International Emerging Infections Program (IEIP)/One Health

The IEIP program partners with the Egypt Ministry of Health to operate a model population-based surveillance site, regional laboratory and training center in the Nile Delta Region. The site is located at Damanhour in the Beheira Governorate (Lower Egypt) with a catchment population of approximately 750,000 residents. This site provides important data, including incidence estimates and the epidemiology and etiology of pathogens associated with respiratory, febrile, and neurologic al infections. The site serves as a platform for research studies and public health training. Human-animal vector studies are also conducted at this site.

C.3.2 Field Epidemiology Training Program (FETP)

GDDRP continues to support the Ministry of Health in FETP development by providing technical assistance and support in the areas of surveillance, epidemiology, outbreak response, and applied public health research. The Egypt FETP program completed an assessment in January 2013 with the assistance of Centers of Disease Control and Prevention (CDC) and regional partners. The results of the assessment guide current program direction, including curriculum development and resident selection.

C.3.3 Influenza

The Sudden Acute Respiratory Infection Surveillance (SARI) Network conducts influenza surveillance activities in 6 countries (Egypt, Jordan, Qatar, Morocco, Pakistan, and Iraq) in the Eastern Mediterranean Region. GDD has worked with partners to build national and governorate-level laboratory and epidemiology capacity for surveillance of influenza and other respiratory viruses of public health concern in support of International Health Regulations (IHR) responsibilities. GDDRP collaborates with WHO EMRO and CDC Headquarters to support influenza surveillance in the region.

C.3.4 Infection Prevention and Control

The Infection Prevention and Control Project (IC) began in 1998 providing technical support to the Egypt Ministry of Health to create a national infection control program. The results of the project were the establishment of an Infection Control Department within the ministry, development of infection control guidelines and training and capacity building of hospital infection control teams. The program has been expanded to include most of the Ministry of Health Hospitals in Egypt. The GDDRP IC team has also supported the development of national strategic plans for infection control programs in Jordan, Oman, and Sudan. Currently, the GDDRP IC unit is expanding its outreach to 40 university hospitals to establish surveillance programs for hospital-acquired infections and antimicrobial resistance.

C.3.5 International Health Regulations/Laboratory Capacity Building

GDD works closely with the Government of Egypt to detect, respond, and notify the international community of emerging infectious disease threats. The laboratory team works with partners to strengthen laboratory capacity development in Egypt and the region toward meeting IHR compliance. Working closely with the Ministry of Health/Central Public Health Laboratory and WHO EMRO, the laboratory team coordinates and conducts laboratory assessments and trainings along with providing quality control/quality assurance and biosafety/biosecurity technical assistance in Egypt and the region (Jordan and Sudan to date).

C.3.6 Infectious Diseases Syndromic Surveillance and evaluation of countermeasures

NAMRU-3 research programs conduct disease surveillance and research and product development in AFRICOM and CENTCOM AOR in partnership with a broad range of stakeholders including other DoD and US interagency partners, academic and industry partners, and host nation MoH, MoD and academia. Data gathered from surveillance activities are used to estimate incidence, prevalence and disease burden – which can inform force health protection planning and can inform the evaluation of potential clinical trial sites for new countermeasures. NAMRU-3 R&D may include basic research and militarily-relevant advanced development, typically in technology readiness levels 3.1-3.3, reflecting historic and ongoing funding streams. NAMRU-3’s current and near-term planned research programs are aimed at characterizing infectious disease pathogens with contemporary and cutting-edge techniques, including the application of second-generation high-throughput genetic sequencing; developing and validating novel assays for better disease detection, and developing/supporting vaccine and therapeutic clinical trials.

C.4 LABOR DESCRIPTIONS FOR NAMRU-3 ORIENTED TASKING

The following descriptions represent the types of labor positions, eligibility requirements, and tasking projected for need by the NAMRU-3 portfolio of research. Eligibility and tasking requirements will be defined/negotiated more specifically at the individual task order level.

Language Proficiency Indicators (used in requirements below). (Language Proficiency must be at the Level I for English unless otherwise indicated below).

Level I Basic Knowledge Level II Limited Knowledge Level III Good Working Knowledge IV Fluent Level V Professional Translator/Interpreter

C.4.1 Administrative Assistant

C.4.1.1 Requirements:

a. Education: University degree required;

b. Prior Work Experience: from 5 to 7 years' experience in administrative and secretarial duties, preferably related to medical sciences.

c. Language Proficiency: Level IV English and Arabic is required.

d. Knowledge: Extensive understanding of Microsoft Word. Shall be able to communicate administrative issues and reports to outside agencies and ministries in Egypt, he/she must have awareness of US Navy regulations. The incumbent must have good command of medical terminology.

e. Skills and Abilities: Experience in computer programs, strong communication skills. Office managing. Ability to make sound decisions and work efficiently and effectively under stress with minimal supervision.

C.4.2 Administrative Clerk

C.4.2.1 Requirements:

a. Education: BA or BS with training; experience in office management and computer data entry.

b. Prior Work Experience: two years' experience in secretarial and administrative duties preferably related to medical science.

c. Language Proficiency: Level III proficiency in English.

d. Knowledge: good knowledge of office management and customer service. Good knowledge of medical terminology. Must have knowledge of systematic filing systems for correspondence and documents. Working knowledge of MS Office programs.

e. Skills and Abilities: Incumbent must have exceptional administrative skills in addition to excellent communication and customer service skills. Must type accurately, and be organized and resourceful. Skilled in computer data entry.

C.4.3 Secretary

C.4.3.1 Requirements:

a. Education: University degree in English or Management. Fluent in Level IV English and Arabic

b. Prior Work Experience: A minimum of five years of experience in secretarial and administrative duties.

c. Knowledge: Thorough knowledge of correspondence practices and office procedures.

d. Skills and Abilities: Ability to communicate effectively. Ability to accurately type organized correspondence at a minimum of 40/wpm, with accuracy. Makes sound decisions and works efficiently and effectively with minimal supervision.

C.4.4 Computer Operator Assistant

C.4.4.1 Requirements:

a. Education: University degree in Computer Science, Information Technology or equivalent.

b. Experience: Two to five years' experience in managing Local Area Networks.

c. Language Proficiency: Level III (working knowledge) written and oral English proficiency required.

d. Knowledge: Strong analytical skills, knowledge of Department of Defense regulations, system security guidelines, antivirus definitions.

e. Skills and Abilities: Must have sound analytical abilities to analyze various factors and conditions of the network and associated systems. Must also have the ability to obtain factual and accurate information from users in the providing of operational and technical assistance; conduct dialogue with users regarding desired training programs; the ability to search computer reference manuals to assist in the performance of assigned duties; and the ability to troubleshoot, diagnose, debug, install, and test PC's and application and network software. Must also be able to exhibit high level of communication skills with all key personnel, office managers, and mission management. Solid experience in Windows Server 2000/2003 and Workstation operating systems, MS Exchange 2003 or later version, System Management Server, DOS, Windows 2000 Professional, Windows XP Professional, and Microsoft Office. Extensive experience in PC support and training is essential.

C.4.5 Computer Manager

C.4.5.1 Requirements:

a. Education: A B.Sc. Degree or equivalent experience in Computer Science. MSCE, Security+ and CCNA certifications. Certification in CISSP.

b. Prior Work Experience: At least ten years performing more responsible work of a program, technical, or administrative nature where emphasis is placed on analytical, judgmental, and expository abilities with respect to the operation, management, and utilization of computer systems. As part of the mentioned experience at least five years must have been work experience in supervisory and project management roles and responsibilities. MCSE and CCNA substitutes for 2 years of experience.

c. Job Knowledge: expert knowledge of computer hardware, computer systems operations and their application, and the policies and procedures relative to equipment requirements planning, acquisition, funding, and justification. Comprehensive knowledge of programs, projects, and organizations supported by the computer and automation support function. Extensive knowledge of the principles, techniques, and methodologies involving computer system analysis, programming, operations, and related aspects of telecommunications. Knowledge of the principles of personnel, financial, and equipment resource management.

d. Language Proficiency: Level IV written and oral English and Arabic proficiency

e. Skills and Abilities: exceptional interpersonal skills. Skilled in supervising subordinates and/or coordinating support services of vendor representatives and other contractors. Must be skilled in using administrative and technical reference material, and relating information therein to technical aspects of management, e.g., systems analysis, design of system architecture, development of standards for tests and evaluation, etc. Must be skilled in applying rules concerning systems acquisition to insure acceptance by of proposals headquarters. Ability to discuss complex concepts with line managers, users, vendors, and other personnel and to relate requirements to computer system capabilities; ability to effectively deal with competing user requirements and to negotiate acceptable solutions; ability to conceptualize objectives of assignments and to translate objectives into concrete plans; ability to assist the CIO obtaining the needed program support.

C.4.6 Storekeeper

C.4.6.1 Requirements:

a. Education: Minimum of High School education is required.

b. Prior Work Experience: Up to 6 months experience in warehousing.

c. Language Proficiency: Level II English.

d. Knowledge: Must be familiar with stock numbers, part numbers and nomenclatures.

e. Abilities and Skills: Must be able to enter data into a computer.

C.4.7 Data Management Clerk

C.4.7.1 Requirements:

a. Education: Secondary School or equivalent is required.

b. Prior Work Experience: A minimum of six months to one-year experience in computer (data management and computer security), performing similar work in a hospital or medical research lab.

c. Language Proficiency: Level III English and Arabic is essential. Typing skills in Arabic are essential.

d. Knowledge: Incumbent must have an excellent knowledge of computer operation to include databases, spreadsheets and word processing. Knowledge of statistical, presentation and computer graphics . General laboratory procedures (serological, bacterial and virology), tests and instrument operation is highly desirable.

e. Skills and Abilities: excellent communication and customer service skills. Ability to work independently as well as part of a small team.

C.4.8 Program Manager

C.4.8.1 Summary: This position is responsible for providing administrative project oversight in order to maximize the effective use of project resources for NAMRU-3. Specific areas include budget and accounting, space management, and personnel management.

C.4.8.2 Essential Tasks:

a. Provides management support and assistance to the Department Heads.

b. Facilitates information flow between program members, Department Heads and the contractor.

c. Prepares reports as needed.

d. Reviews space utilization within the program and makes recommendations accordingly.

e. Provides oversight to budgets, accounting, and purchasing and facilitates payment of invoices/purchase orders.

f. Directs, coordinates, and conducts contractor personnel actions and furnishes guidance and assistance as needed.

g. Provides guidance on manpower utilization, work flow, and operational procedures to increase efficiency, productivity, and make overall improvements for the program.

C.4.8.3 Required Knowledge, Skills, and Abilities:

a. Knowledge of Human Resources management practices, laws, and approaches.

b. Knowledge of budgets and accounting.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in writing memorandums, letters, and other correspondence.

e. Skilled in visualizing beneficial changes in office administration.

f. Ability to provide suggestions and implement improvements in identified office procedures.

g. Ability to plan and prioritize work.

h. Ability to be a self-starter and work independently.

i. Ability to interface with investigators, vendors, research staff, and study participants

C.4.8.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a college degree in Human Resources Management, Business Administration, or related field plus 4 to 6 years of related experience. Equivalent of an advanced degree is preferred, but not required.

C.4.9 Laboratory Assurance Specialist

C.4.9.1 Summary: This position provides routine and non-routine QA support for the departments to enhance operating efficiency and uses independent judgment in the resolution of QA problems related to College of American Pathologist (CAP) laboratory tasking.

C.4.9.2 Tasks:

a. Designs, troubleshoots, and maintains the quality assurance plan.

b. Monitors laboratory challenges and hosts monthly update meetings for future prevention.

c. Serves as point of contact to maintain the laboratory’s College of American Pathologist

a. (CAP) accreditation.

d. Oversees proficiency exam schedules for the laboratory.

e. Writes, reviews, and facilitates approval of Standard Operating Procedures (SOPs) for the laboratory according to applicable guidelines.

f. Provides secondary review of laboratory reports and other clinical data as necessary.

g. Conducts QA audits of the laboratory sections and clinical study processes and documents.

h. Prepares reports of all findings for reference.

C.4.9.3 Required Knowledge, Skills, and Abilities:

a. Knowledge of microbiology, laboratory and safety procedures.

b. Knowledge of College of American Pathology regulations.

c. Knowledge of CLIA and OSHA safety requirements.

d. Knowledge of proper handling of chemicals and biohazard materials.

e. Knowledge of standard laboratory equipment.

f. Knowledge of a centralized documentation (version control) system.

g. Skilled in the use of word processing, spreadsheet, email, graphic, database, and scanning software.

h. Skilled in writing abstracts, reports, correspondence, and research funding proposals.

i. Ability to organize, plan and prioritize work.

j. Ability to be a self-starter and work independently.

k. Ability to interface with investigators, research staff, and study participants.

l. Ability to create and enforce standard operating procedures.

C.4.9.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a college degree in Biology, Microbiology, Medical Technology, or a related field and at least 4 years of related experience. A license in Medical Technology, MT (ASCP) or equivalent, is not required, but is strongly recommended.

C.4.9.5 Work Environment: Office work environment with some exposure to a clinical laboratory.

C.4.10 Document Control Specialist

C.4.10.1 Summary: This position is responsible for assigning document numbers, issuing QA approved effective copies, distributing and tracking electronic and hard-copy controlled documents, and maintaining associated logs in accordance with the appropriate corporate and regulatory agency requirements.

C.4.10.2 Tasks:

a. Maintains master document lists as required.

b. Maintains electronic/paper copies, and distributes QA approved control document electronic templates for standard operating procedures, test methods, and other documentation as required.

c. Maintains a centralized documentation system for all laboratory records, SOPs and forms, and keeps record of all document numbers, document versions, superseded documents and retired documents for reference.

d. Distributes current forms and SOPs as approved by Quality Assurance to the laboratories for their reference and use.

e. Updates the laboratory intranet website, which provides an electronic form of all current SOPs, forms, permits and laboratory certificates.

C.4.10.3 Required Knowledge, Skills, and Abilities

a. Knowledge of GCP/GLP/GMP regulations.

b. Knowledge of a centralized documentation (version control) system.

c. Must have excellent computer, writing, and communication skills.

d. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

e. Ability to plan and prioritize work as directed.

f. Ability to do long periods of repetitive work.

g. Ability to follow standard operating procedures.

h. Ability to be a self-starter and work without direct supervision.

i. Ability to have attention to detail and be extremely organized.

j. Ability to interface with senior scientists, vendors and research staff.

C.4.10.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a high school diploma and a minimum of two years’ experience in document control.

C.4.10.5 Work Environment: Office work environment with limited exposure to a clinical laboratory.

C.4.11 Molecular Biologist

C.4.11.1 Summary: This position performs routine and non-routine laboratory procedures for the department to enhance laboratory efficiency, and uses independent judgment to resolve administrative/data problems.

C.4.11.2 Tasks:

a. Uses senior independent judgment to perform basic to advanced microbiology (bacteriology, virology, and serology) procedures in support of NAMRU-3 efforts.

b. Provides senior oversight of training contractor technicians and bench work.

c. Provides senior oversight of contractor supervisor in setting up new test procedures.

d. Provides senior oversight of required quality control procedures being performed for every test done and of recording data in the designated logbook or worksheet.

e. Provides senior oversight for inventory of isolates and controls.

f. Creates and presents abstracts and papers at scientific conferences.

g. Provides oversight of receiving specimens and reporting results.

h. Performs computer data entry of lab results and other lab information.

C.4.11.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of current molecular research technologies and practices.

b. Advanced knowledge of standard laboratory equipment and safety procedures.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of pipettes, microscopes, staining procedures.

e. Skilled in the use of aseptic techniques.

f. Ability to be trained of proper throat, urine, and blood collection techniques.

g. Ability to plan and prioritize work.

h. Ability to distinguish colors (for purposes of lab procedures).

i. Ability to do long periods of repetitive work.

j. Ability to correctly transcribe laboratory results.

k. Ability to follow standard operating procedures.

l. Ability to be a self-starter and work independently.

m. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.11.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a Ph.D. or M.D. level college degree in Molecular Biology, Microbiology, or Medical Technology, and 4 years of related experience at the Ph.D. or M.D. level.

C.4.11.5 Work Environment: Clinical laboratory working conditions – Handles hazardous waste materials. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.12 Database Administrator

C.4.12.1 Summary: The position provides routine and non-routine data support for the department to enhance operating efficiency, and uses independent judgment to resolve administrative/data problems.

C.4.12.2 Tasks:

a. Manages and maintains comprehensive data, ensuring consistency and integrity.

b. Administers, maintains, develops and implements policies and procedures for ensuring the security and integrity of databases.

c. Conducts needs assessments, designs and creates databases, and participates in testing and implementation of new applications and/or enhancements and modifications to existing systems.

d. Designs, modifies, develops, writes and implements software programming applications.

e. Implements data models and database designs, data access and table maintenance codes.

f. Supervises or oversees the work of programming and web development contractor staff.

g. Resolves database performance issues, database capacity issues, replication, and other distributed data issues.

h. Provides assistance and training to system users.

i. Develops and designs methods and procedures for collecting, organizing, interpreting, and classifying information for input into computer and retrieval from computer, utilizing knowledge of symbolic language, optical or pattern recognition, database construction, and retrieval methods.

C.4.12.3 Required Knowledge, Skills, and Abilities:

a. Ability to design and implement systems necessary to collect, maintain, and analyze data.

b. Ability to communicate effectively, both orally and in writing.

c. Ability to resolve data input, storage, and/or retrieval problems and to design solutions and modifications to prevent future complications.

d. Knowledge of mathematics.

e. Ability to verify data input and correct errors.

f. Knowledge of current technological developments/trends in area of expertise.

g. Knowledge of computer data processing principles.

h. Ability to implement and troubleshoot programming changes and modifications.

i. Ability to supervise contractor personnel and train assigned staff.

j. Ability to create data capture and input specifications.

k. Knowledge of structured programming, testing, and debugging techniques.

l. Ability to interact with students, faculty and/or staff in a team environment.

m. Knowledge of database construction, management, and retrieval methods.

n. Ability to provide a range of systems training and/or support activities for users.

o. Ability to analyze operational data requirements and to create and develop databases specific to requirements.

C.4.12.4 Minimum Education/Training/Experience Requirements: Bachelor's degree; at least 2 years of experience that is directly related to the duties and responsibilities specified or successful completion of at least 60 college-level credit hours; at least 4 years of experience that is directly related to the duties and responsibilities specified.

C.4.13 Research Study Coordinator

C.4.13.1 Summary: The position provides routine and non-routine laboratory support and study coordination for the department to enhance operating efficiency. This position is responsible for data collection, data management, and graphical data preparation, as well as preparing IRB documents and protocols.

C.4.13.2 Tasks:

a. Collects and organizes data for laboratory projects.

b. Responsible for coordination of the review and submission of all protocols.

c. Prepares technical reports, summaries, IRB documents and protocols.

d. Handles questions from PIs, coordinators, and the IRB chair related to submission and review requirements.

e. Establishes and maintains databases for projects.

f. Provides supervision, training and directs work assignments to research assistant contractor personnel.

g. Retrieves information from databases and other multiple data sources.

h. Provides laboratory and management reports.

i. Coordinates shipping of specimens from study sites.

C.4.13.3 Required Knowledge, Skills, and Abilities:

a. Basic knowledge of epidemiology.

b. Knowledge of basic disease etiologies and preventive strategies.

c. Knowledge of IRB protocol procedures.

d. Knowledge of survey methods and basic statistics used to collect and interpret data.

e. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

f. Skilled in writing memorandums, correspondence, abstracts, articles, and proposals.

g. Ability to plan and prioritize work.

h. Ability to supervise and direct work assignments.

i. Ability to exercise independent judgment in the resolution of problems.

j. Ability to make presentation to groups.

k. Ability to be a self-starter and work independently.

l. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.13.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a college degree in Public Health or related field plus 2-4 years of related experience. An advanced degree is preferred, but not required.

C.4.14 Microbiologist

C.4.14.1 Summary: This position is responsible for overseeing all daily aspects of laboratory procedures, results, contractor laboratory personnel, and safety in the laboratory section assigned.

C.4.14.2 Tasks:

a. Responsible for helping to identify disease situations and to design proper laboratory support for these projects.

b. Has firsthand knowledge of laboratory techniques in the isolation, identification, and characterization of microorganisms.

c. Updates laboratory capabilities with new technologies as necessary and feasible.

d. Supervises and trains contractor lab personnel in procedures of testing, equipment, safety and quality control.

e. Creates and presents abstracts and papers at scientific conferences.

f. Must uphold all policies and procedures based on current and/or future accrediting organizations.

g. Checks required quality control results for every test done.

h. Writes, reviews, and updates standard operating procedures for assigned laboratory section.

i. Responsible for assuring all results released are accurate and timely.

j. Monitors quality assurance for assigned laboratory section.

C.4.14.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of microbiology and current research technologies and practices.

b. Advanced knowledge of laboratory equipment and laboratory safety procedures.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of pipettes, microscopes, staining procedures and aseptic techniques.

e. Ability to plan and prioritize work.

f. Ability to supervise contractor personnel and train contractor technicians and direct work assignments.

g. Ability to distinguish colors (for purposes of lab procedures).

h. Ability to make presentation to groups.

i. Ability to write manuscripts and abstracts.

j. Ability to do long periods of repetitive work.

k. Ability to correctly transcribe laboratory results.

l. Ability to create and enforce standard operating procedures.

m. Ability to be a self-starter and work independently.

n. Ability to interface with investigators, vendors, research staff, and study participants

C.4.14.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a college degree in Biology, Microbiology, Medical Technology, or a related field and 4 years of related experience (one of which is in microbiology) under a qualified laboratory director. A license in Medical Technology, MT (ASCP), or equivalent, is required.

C.4.14.5 Work Environment: Clinical laboratory working conditions – Handle hazardous waste materials. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.15 Microbiology Technologist

C.4.15.1 Summary: This position performs routine and non-routine laboratory procedures for the department to enhance laboratory efficiency. This position exercises independent judgment in the resolution of laboratory problems.

C.4.15.2 Tasks:

a. Uses independent judgment to perform basic to advanced microbiology (bacteriology, virology, and serology) procedures to include pipetting, bacteriology isolation techniques, microscope work, and staining slides.

b. Trains contractor technicians and supervises bench work in the absence of the contractor supervisor.

c. Assists contractor supervisor in setting up new test procedures.

d. Performs required quality control procedures for every test done and keeps a record in the designated logbook or worksheet.

e. Keeps an accurate inventory of isolates and controls.

f. Creates and presents abstracts and papers at scientific conferences.

g. Receives specimens and report results.

h. Performs computer data entry of lab results and other lab information.

C.4.15.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of microbiology and current research technologies and practices.

b. Advanced knowledge of laboratory equipment and laboratory safety procedures.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of pipettes, microscopes, staining procedures.

e. Skilled in the use of aseptic techniques.

f. Ability to be trained of proper throat, urine, and blood collection techniques.

g. Ability to plan and prioritize work.

h. Ability to distinguish colors (for purposes of lab procedures).

i. Ability to do long periods of repetitive work.

j. Ability to correctly transcribe laboratory results.

k. Ability to follow standard operating procedures.

l. Ability to be a self-starter and work independently.

m. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.15.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a Bachelor’s level college degree in Molecular Biology, Microbiology, Medical Technology, or a related field and 1 to 3 years of related experience.

C.4.15.5 Work Environment: Clinical laboratory working conditions – Handles hazardous waste materials. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.16 Microbiology Technician

C.4.16.1 Summary: This position performs routine and non-routine laboratory procedures for the department to enhance laboratory efficiency. This position exercises independent judgment in the resolution of laboratory problems.

C.4.16.2 Tasks:

a. Using standard operating procedures, technician performs basic microbiology procedures as instructed by a contractor supervisor to include microscope work, pipetting, tissue culture techniques, and virus isolation and identification.

b. Performs required quality control procedures for every test done and keeps a record in the designated logbook or worksheet.

c. Keeps an accurate inventory of isolates and controls.

d. Receives specimens and report results.

e. Performs computer data entry of lab results and other lab information.

C.4.16.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of microbiology and current research technologies and practices.

b. Advanced knowledge of laboratory equipment and laboratory safety procedures.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of aseptic techniques.

e. Ability to plan and prioritize work.

f. Ability to pipette, use of microscopes, and perform staining procedures.

g. Ability to distinguish and identify different colors.

h. Ability to do long periods of repetitive work.

i. Ability to correctly transcribe laboratory results.

j. Ability to follow standard operating procedures.

k. Ability to be a self-starter and work independently.

l. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.16.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a college degree in Biology, Microbiology, Medical Technology, or a related field and 0 to 2 years of related experience.

C.4.16.5 Work Environment: Clinical laboratory working conditions – Handles hazardous waste materials. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.17 Molecular Laboratory Technologist

C.4.17.1 Summary: This position performs routine and non-routine laboratory procedures for the department to enhance laboratory efficiency. This position exercises independent judgment in the resolution of laboratory problems.

C.4.17.2 Tasks:

a. Uses independent judgment to oversee basic to advanced molecular research efforts.

b. Trains contractor technicians and supervises bench work in the absence of the contractor supervisor.

c. Assists contractor supervisor in setting up new test procedures.

d. Performs required quality control procedures for every test done and keeps a record in the designated logbook or worksheet.

e. Keeps an accurate inventory of isolates and controls.

f. Creates and presents abstracts and papers at scientific conferences.

g. Receives specimens and report results.

h. Performs computer data entry of lab results and other lab information.

C.4.17.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of current molecular research technologies and practices.

b. Advanced knowledge of standard laboratory equipment and safety procedures.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of pipettes, microscopes, staining procedures.

e. Skilled in the use of aseptic techniques.

f. Ability to be trained of proper throat, urine, and blood collection techniques.

g. Ability to plan and prioritize work.

h. Ability to distinguish colors.

i. Ability to do long periods of repetitive work.

j. Ability to correctly transcribe laboratory results.

k. Ability to follow standard operating procedures.

l. Ability to be a self-starter and work independently.

m. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.17.4 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a Bachelor’s level college degree in Molecular Biology, Microbiology, Medical Technology, or a related field and 2 to 4 years of related experience.

C.4.17.5 Work Environment: Clinical laboratory working conditions – Handles hazardous waste materials. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.18 Research Technician 3

C.4.18.1 Summary: This position provides laboratory and technical support to senior technical and professional staff for specialized testing and projects.

C.4.18.2 Tasks:

a. Uses independent judgment to perform specialized testing for advanced microbiology

a. (bacteriology, virology, and serology) procedures to include pipetting, bacteriology isolation techniques, microscope work, and staining slides.

b. Researches and implements cutting edge techniques.

c. Utilizes specialized training in virology for the characterization of influenza.

d. Performs specialized Healthcare Associated Infections (HAI) techniques in the laboratory.

e. Assists director and senior scientists with setting up new test procedures.

f. Performs required quality control procedures for every test done and keeps a record in the designated logbook or worksheet.

g. Keeps an accurate inventory of isolates and controls.

h. Creates and presents abstracts and papers at scientific conferences.

i. Occasionally obtains throat swab and/or blood sample specimens.

j. Receives specimens and report results.

k. Performs computer data entry of lab results and other lab information.

C.4.18.3 Required Knowledge, Skills, and Abilities:

a. Advanced knowledge of microbiology, basic laboratory, and safety procedures.

b. Knowledge of standard laboratory equipment.

c. Skilled in the use of word processing, spreadsheet, graphic, email, and database software.

d. Skilled in the use of pipettes, microscopes, staining procedures.

e. Skilled in the use of aseptic techniques.

f. Ability to be trained in proper throat, urine, and blood collection techniques.

g. Ability to plan and prioritize work.

h. Ability to distinguish colors (for purposes of lab procedures).

i. Ability to do long periods of repetitive work.

j. Ability to correctly transcribe laboratory results.

k. Ability to follow standard operating procedures.

l. Ability to be a self-starter and work independently.

m. Ability to interface with investigators, vendors, research staff, and study participants.

C.4.18.3 Minimum Education/Training/Experience Requirements: This position requires the equivalent of a Bachelor’s level college degree in Molecular Biology, Microbiology, Medical Technology, or a related field and 4 years of related experience.

C.4.18.4 Work Environment: Clinical laboratory working conditions – Handles hazardous waste material. Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures.

C.4.19 Research Technician 2

C.4.19.1 Summary: This position performs routine and non-routine laboratory procedures for the department to enhance laboratory efficiency. This position exercises independent judgment in the resolution of laboratory problems.

C.4.19.2 Tasks:

a. Performs basic molecular biology procedures as instructed by a contractor supervisor.

b. Performs required quality control procedures for every test done and keeps a record in the designated logbook or worksheet.

c. Keeps an accurate inventory of…