N6264519R0057.docx

N6264519R0057

Section B - Supplies or Services and Prices

NAMRU-6 Research Support Services - CPFF

CPFF

Cost Plus Fixed Fee Task Orders

The total value of this CLIN is the maximum value (combined value of all task orders) for all CPFF task orders that can be issued against the base contract.

MAXIMUM ALLOWABLE ODCs: To be filled in at the task order level.

MAXIMUM ALLOWABLE TRAVEL: To be filled in at the task order level.

FOB: Destination

PSC CD: AN42

MAX COST

FIXED FEE

TOTAL MAX COST + FEE

Section C - Descriptions and Specifications

PWS

NAVAL MEDICAL RESEARCH UNIT-6 RESEARCH AND ADMINISTRATIVE SUPPORT SERVICES

1.0 INTRODUCTION AND BACKGROUND:

1.1 The PWS located in Section C of the base contract applies to all subsequent task orders issued under the base contract.

1.2 The Naval Medical Research Unit-6 (NAMRU-6) mission is to conduct biomedical research in the field of infectious diseases and global health that is responsive to U.S. Navy requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the effectiveness of the uniformed service members through respectful cooperation with our collaborators. NAMRU-6 is a component of the Navy Bureau of Medicine and Surgery (BUMED).

The vision of NAMRU-6 is to be the premier tri-service overseas biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, and sustains uniformed service members today, invents global medical solutions for the future, and keeps service members and Allies on point for the Nation.

NAMRU-6 conducts research studies in support of the readiness and Force Health Protection (FHP) of US military personnel. In addition, NAMRU-6 conducts basic research and provides sustainable infectious disease research support to the host nation Ministry of Health, military, and universities through field studies, infectious diseases surveillance, vaccine and drug clinical trials, test & evaluation of new infectious diseases detection/diagnosis technologies and training. NAMRU-6 also conducts field/medical entomology, epidemiologic studies and disease bio-surveillance of a wide range of infectious diseases of military and/or public health significance in the U.S. Southern Command (USSOUTHCOM) area of responsibility.

NAMRU-6 ensures that, when feasible, host nation investigators are included in the planning, performance, and publication of NAMRU-6 research, thereby providing the most effective sustainable improvement in infectious disease research.

1.3 The effort required under this Performance Work Statement (PWS) is to provide non-personal research support services to NAMRU-6.

2.0 ASSUMPTIONS AND CONSTRAINTS

2.1 All task orders issued under this base Indefinite Delivery Indefinite Quantity (IDIQ) - contract will be Cost Plus Fixed-Fee (CPFF). All task orders issued under this contract will be for non-personal services.

2.2 For task orders that are considered severable services, the task order will be performance based and will include a Performance Work Statement (PWS) that identifies the tasks to be performed and a Quality Assurance Surveillance Plan (QASP) that establishes performance metrics for these tasks.

2.3 For task orders that are considered non- severable services, the task order will not be performance based and will not include a PWS or a QASP. Task orders for non-severable services will include a Statement of Work (SOW).

2.5 Severable task orders will not have a Period of Performance (POP) of more than twelve (12) months (without exercising an option period). The POP for a Non Severable task order will be dependent on the nature of the task. The POP for each task order will be delineated in the Task Order Proposal Requests (TOPR)

2.6 TOPRs will include the Government’s Estimated Level of Effort (LOE). The Government’s estimate will include the estimated labor mix (comprised of labor categories from the base contract PWS) and the estimated LOE will include the number of Full Time Employees (FTE). If applicable, TOPRs will also include estimated Other Direct Cost (ODC) Travel and Subcontract amounts. The TOPR will also include the required assurances for human subject research or animal research (if applicable). In addition the TOPR will contain all other information for the contractor to propose, such as the necessary security clearance level and insurance requirements etc.

2.7 All labor categories performing under task orders issued under the base contract require a background investigation in accordance with the DODI 5200.02 and DODI 1000.13. A facility level clearance is not required. Labor categories may require a security clearance up to the level of Secret. Contractors who require access to NAMRU-6 Government computer systems (requiring a Common Access Card or CAC) are required to be fingerprinted. The exact requirements for security levels will be delineated at the task order level.

The Regional Security Office (RSO), U.S. Embassy, Lima, Peru serves as the investigative authority for NAMRU-6.

2.8 This effort is not considered a new requirement (legacy contract N62645-16-F-0066, Parsons Government Services) and therefore the right of first refusal concerning incumbent employees with the successful offeror may apply.

2.9 Intramural human use research is expected under the task orders that will be issued under this base IDIQ contract. Research with human subjects shall not begin until the contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). A Human Research Protection Officer (HRPO) review must be in place before any funding can be placed on a task order (or on any Option CLIN where human use research is segregated from the remainder of the task order).

2.10 Intramural human use research can include interaction with study participants. When interaction with study participants is required, the contractor shall possess medical liability and indemnity insurance. The Federal Tort Claims Act does not apply. The requirement for medical liability and indemnity insurance will be delineated at the task order level.

2.11 Intramural animal use is expected under the task orders that will be issued under this base IDIQ. Task orders involving the use of animals in research shall be compliant with all applicable federal and DoD regulations, specifically including 7 U.S.C. 2131 et. Seq. and 9 CFR 1-4, “Animal Welfare Act”; DoDI 3216.01, “Use of Animals in DoD Programs”; and specific DoD component management plans. The contractor shall support the investigation of animal use and care regulations and the establishment of training plans developed to educate researchers regarding their animal use and care responsibilities. The contractor shall support Institutional Animal Care and Use Committee (IACUC) functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation, Department of Health and Human Services (DHHS) Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections.

2.12 Travel is expected in support of the research efforts at NAMRU-6. Travel approval must be processed in accordance with NAMRU-6 procedures, in accordance with Joint Travel Regulations, documented and submitted with monthly reports and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of the Contracting Officer’s Representative (COR). All travel must be approved by the COR in writing via e-mail prior to the contractor incurring costs.

The Government retains the right to direct the mode of travel including the availability and size of rental cars. It should be noted that vendors are not obligated to extend discounted Government rates to contractors working on behalf of the Federal Government.

An estimated travel cost will be delineated at the task order level. The estimated travel cost shall not include fee or contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

Please refer to Section H, “REIMBURSEMENT OF TRAVEL, PER DIEM, AND SPECIAL MATERIAL COSTS”, for further details.

2.13 Other Direct Costs (ODC) are expected in support of the research efforts at NAMRU-6. ODCs may include equipment, research supplies, services and other costs that will accomplish the mission objectives such as FDA and local regulatory authorities applications, study start-up planning, statistical analysis support, study site rentals, medical indemnity/liability insurance, internet services, cloud services, mobile data/communications equipment and services, shipping/transportation fees, transportation that directly supports clinical trials and other research field studies and research subject compensation. All ODC costs (to include gift cards to compensate study participants) must be approved by the COR in writing via e-mail prior to the contractor incurring costs.

An estimated ODC amount will be delineated at the task order level. The ODC amount shall not include fee or contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

Please refer to Section H, “REIMBURSEMENT OF TRAVEL, PER DIEM, AND SPECIAL MATERIAL COSTS”, for further details.

2.14 Subcontracts: Subcontracts are expected in support of the research efforts at NAMRU-6.The awardee must have the capacity to award subcontracts as needed to meet research and development needs. Subcontracts could include (but are not limited to): rent of space for sample storage, rent of office space or research facility with a security system (to execute clinical trials or field research activities, such as performing subject recruitment, initial evaluation, and follow up visits), support from clinical research organizations (CRO), data analysis and management, clinical monitoring and data quality assurance and regulatory filing and support.

An estimated subcontracts amount will be delineated at the task order level. The subcontracts amount shall not include fee or contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

2.15 There is a potential Organizational Conflict of Interest (OCI) at the task order level. The potential OCI is that contractor personnel may have access to financial data regarding funding for research studies. Contractors may also be assisting the Government in the preparation of intramural and extramural grant applications for studies. Since there is a potential OCI, the offeror’s proposal shall include an OCI Mitigation Plan for review/approval by the Government / Contracting Officer. In consideration of the contractor's legacy work currently being performed under other contracts or future work to be bid or performed, the Contractor warrants that no OCI condition will be created by acceptance of this base IDIQ contract award or any subsequently awarded task orders. The OCI Mitigation Plan shall include Non-disclosure Agreements signed by the personnel performing on this task order and counter-signed by their management. The OCI Mitigation Plan and NDAs shall state: “This document does not authorize access to another company’s proprietary or sensitive information.”

2.16 The Government estimates a full time equivalent (FTE) at 1920 hours (One FTE = 1920 hours (2080 hours – 80 hours holidays – 80 hours PTO)) for the purposes of the estimated level of effort that is provided at the task order level. The Government estimate is provided so that all offerors are aware of the Governments’ estimated level of effort for each task order. Positions may be requested at less than a full time status.

2.17 Government Vehicle Use: There may be circumstances requiring contract personnel ride in a Government vehicle in the performance of conducting various research study requirements, including but not limited to travel to field or remote sites, relocation of research equipment, or transportation of research subjects. Government vehicle use will be on official business for non-personal service in accordance with NAMRU-Six’s instruction. If contractor use of GSA Fleet vehicles is allowable under NAMRU-6’s GSA lease agreement, vehicles are available for use and such use will result in a significant savings to the Government; the Government will consider allowing Contractor personnel to use GSA Fleet vehicles and related services in performance of the contract. Contractor use of GSA fleet vehicles will be delineated at the task order level (if applicable).

2.18 Work Location and Schedule: NAMRU-6 is headquartered in Lima, Peru. NAMRU-6 also has a Naval Laboratory in Iquitos (Loreto), Peru, a Naval Laboratory in Puerto Maldonado (Madre de Dios), Peru and a satellite laboratory at U.S. Joint Task Force-Bravo (JTF-B), Soto Cano Air Force Base in Comayagua, Honduras.

Other locations where research support services may be required at are (located in Peru unless a separate country is noted): Centro de salud de Pachitea, Piura, Hospital Santa Gema, Yurimaguas, Loreto, Cuzco Piura, Tumbes, Bagua (Amazonas), Yurimaguas and Iquitos (Loreto), Trujillo (La Libertad), La Merced (Junin), Cuzco, Cartagena, Medellin, Villavicencio (Bogota), Cobenas (Colombia), San Pedro de Sula and Tegucigalpa (Honduras), Ecuador. The locations provided above are examples and the exact locations will be delineated at the task order level.

The normal work schedule is outlined in Section H. Due to the nature of this support, work outside of core hours is authorized, on an as-needed basis, and at the discretion of the government. Work outside of normal hours will be authorized by the COR.

The need for telework will be delineated at the task order level. Telework may be granted on a case-by-case basis and must be endorsed by the NAMRU-6 COR and approved by the NMLC Contracting Officer via a post award modification. If endorsed by the COR, telework is not permitted unless the task order is modified by the Contracting Officer to lift the restriction on teleworking. Contractor personnel shall be listed by name and the applicable GFP information shall be included in the task order PWS via a modification to the task order.

2.19 Government Furnished Property (GFP) and Contractor Acquired Property: The Government may provide some necessary research equipment, supplies, and office supplies to conduct tasks under this contract. For contractor personnel, including (subcontractor personnel) working in a DoD facility in Lima and Iquitos, Peru, Government will provide all information technology and laboratory equipment requirements. Contractor personnel assigned to specific sites other than the facilities in Lima and Iquitos, Peru may be required to provide ancillary support services, research equipment, laboratory supplies, and office supplies necessary to accomplish all of their work. The contractor will be responsible for implementing property management procedures for accountability and reporting of GFP issued to contractor personnel, including Subcontractor personnel. GFP will be delineated at the task order level.

2.20 Contingency Situations: Contingency situations (natural disasters, military peacetime and wartime contingency operations/exercises, serious accidents, civil disturbances, major mobilization or repatriation of non-combatants) may necessitate that the contractor be flexible in arranging different levels of support and service operational hours. The contractor shall respond to contingency situations and revise priorities as directed by the COR. If the contractor cannot accomplish normal activities due to activation or exercise of any contingency plan, the contractor shall not be held liable for nonsupport of lower priorities. The Government will determine the priorities that can be temporarily relaxed in contingency situations.

If appropriate, the contractor shall be reimbursed for contingency operations requiring a higher level of response and resources. The contractor shall submit a request for equitable adjustment detailing the impact resulting from the incorporation and operation of such contingency actions prior to the beginning of the contingency operations.

In the event that NAMRU-6 operations are curtailed as a result of weather emergencies or other unplanned mission-related events, contractor personnel may be considered non-essential personnel and thus, are not required to be at the work site. They may, however, be required to be on call, to work at a designated evacuation site, to telework (if authorized), or to be part of a crisis response team at a nearby site.

The Contracting Officer shall be notified by the COR (as soon as it is reasonable to do so), if any part of section 2.20 becomes applicable.

2.21 Access to Government Controlled IT Networks: If the COR determines that contract personnel require access to a Government computer network, the contractor shall provide all requested information to the Embassy Regional Security Office via NAMRU-6 Administration Department prior to access and continuation of tasks. The requirement for access to Government controlled IT networks will be delineated (on a position basis) at the task order level.

2.22 For executing tasks for Clinical Trials, the prime contractor (or a subcontractor) shall possess and demonstrate the ability to conduct clinical trials in Peru or show the ability to subcontract with a contractor that is capable of conducting clinical trials in Peru. They shall be certified by the General Office for Research and Technology Transfer (OGITT, OGIT in Spanish); this entails being registered at the Peruvian Clinical Trial Registry (REPEC) to conduct clinical trials in the field of infectious diseases. If the ability to conduct clinical trials in Peru is held by a subcontractor, and the Prime and Subcontractor end their contractual relationship, the Prime contractor shall notify the Contracting Officer within 24 hours.

2.23 Options on Task Orders: Task orders may contain option periods. The Contracting Officer may exercise options only after determining that (1) funds are available, (2) the requirement covered by the option fulfills an existing Government need and (3) successful performance of the contractor in the preceding performance period.

3.0 MANAGEMENT

The contractor shall provide direct on-site supervision of all personnel and provide direct on-site management functions for contractor personnel such as timekeeping, leave, pay, benefits, performance reporting, and all related human resourcing, supervision, and management functions. The contractor shall ensure all contractor personnel are aware that all such functions are to be performed by the contractor’s management and issues or problems related to these areas should not be discussed with Government employees. The contractor will clearly communicate to contractor personnel who their point of contact is for these matters.

The Government retains no direct control of the contractor or its personnel and how they render services. The contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or personnel. The contractor will assume all responsibility and liability for any and all personal injuries or death and/or property damage or losses suffered due to the negligence of the contractor’s personnel in the performance of services under this contract. The contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government.

The Commanding Officer of NAMRU-6 maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

4.0 SCOPE OF WORK

4.1 Departments/General: The contractor shall provide research support services to the following NAMRU-6 departments:

Scientific Departments: Bacteriology, Biomedical Informatics, Entomology, Parasitology, Veterinary services, Virology and Emerging Infections, Clinical Trials and Research Administration Program.

Support Departments and Programs: Command Suite, Resource Management Directorate, Directorate for Administration, Materiel Management, Engineering and Facilities, Occupational Health, Information Management/ Information Technology, and Safety/Environmental.

The support departments and programs provide financial and administrative support to the scientific departments.

The Contractor will provide all managerial, administrative, direct labor personnel, materials, transportation, and other pertinent services that are necessary to accomplish all work required. For contractor at NAMRU-6 sites in Iquitos and Lima and at other specified locations, NAMRU-6 may provide office supplies, cleaning supplies, printing supplies, office furniture, communications device and government furnished equipment (GFE) to accomplish the work. At more remote study sites, these items will be provided by the contractor as ODCs. The GFE provided will be delineated at the task order level.

The Contractor shall support research such as (but not limited to) a) vaccine trials b) drug studies c.) test and evaluation of new technology, d.) epidemiologic studies and biosurveillance of infectious diseases, surveillance of vectors, e.) development / evaluation of devices and therapeutic countermeasures for malaria, bacterial causes of infectious diarrhea, emerging viral pathogens (e.g., dengue, chikungunya, Zika), influenza viruses, leishmaniasis, and multi-drug resistant bacteria. The contractor shall support the collection of data and support regulated studies. The Contractor shall provide support in maintaining U.S. Federal Drug Administration (FDA) regulatory standards to conduct clinical studies in accordance with Good Clinical Practices (GCP) and the International Conference on Harmonization (ICH).

4.2 Bacteriology. The contractor shall support the following research objectives:

4.2.1. Main research objectives/areas:

a. Global partner on diarrhea surveillance and pathogen characterization.

b. Vaccine development against enteric pathogens (e.g., Enterotoxigenic Escherichia Coli [ETEC], Shigella, Campylobacter).

c. Epidemiology of hospital-acquired infections and antibiotic resistance surveillance.

d. Surveillance of sexually transmitted infections (STIs) and human immunodeficiency (HIV) prevention.

e. Use of bacteriophages as therapeutics.

4.2.2 Diagnostic assay development:

a. Development of polymerase chain reaction (PCR) assay to detect clustered regularly-interspaced short palindromic repeats (CRISPR) sequences for rapid identification of antibiotic resistant bacteria.

b. Antigen discovery for development of rapid field test for pathogenic Leptospira in clinical and environmental sources.

c. Evaluation of FilmArray field testing for detection of diarrheal and respiratory pathogens in operational environments.

4.2.3 Drug Testing/Therapeutics/Interventions:

a. Clinical trials of antibiotic prophylaxis and optimized treatment regimens against diarrhea in deployed U.S. military.

b. Development of bacteriophage cocktails against drug-resistant wound pathogens Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus.

c. Evaluation of HIV prevention and education strategies in military populations.

d. Phase 2, Phase 3 and Phase 4 trials in support of DOD programs of records and pharma investigational new drug applications (INDs) and new drug applications (NDAs) for the benefit of the warfighter.

4.3 Biomedical Informatics (BID). The contractor shall support the following research objectives:

4.3.1 BID staff is comprised of subject-matter experts in public health and information and communication technologies professionals who work on the development, implementation, adoption, monitoring, and evaluation of informatics solutions for capture, transmission, storage, visualization, and dissemination of medical and public health information.

4.3.2 Main department objectives. The contractor shall support the following research objectives:

a. Develop a centralized unified system for data management and quality assurance (QA) and collaborate with strategic partners to build technical informatics capacity in host countries through research, development, testing, and evaluation of products and services in the intersection of information and communication technologies, biomedical science and public health.

4.4 Entomology. The contractor shall support the following research objectives:

4.4.1 Main research objectives:

a. Test novel topical and spatial repellents.

b. Development support for Plasmodium vivax vaccine.

c. Vector incrimination of mosquitoes and sandflies.

d. Biology, taxonomy, distribution of vectors in Latin America.

e. As part of the Military Infectious Diseases Research Program (MIDRP) and Deployed War-Fighter Protection Program (DWFP), NAMRU-6 supports testing and development of spatial repellents for protection forward deployed troops in the SOUTHCOM area of responsibility.

f. As part of the MIDRP, support production of Plasmodium vivax sporozoites for use in the DoD Malaria Vaccine Research Program.

g. Testing of novel control tools, such as insecticides (e.g., Ivermectin) to protect forward deployed troops.

h. GEIS supported surveillance and identification of important insect vectors in Peru and across SOUTHCOM region to develop real-time risk models for control of vector-borne pathogens.

4.5 Parasitology. The contractor shall support the following research objectives:

4.5.1 Main research objectives:

a. Conduct disease surveillance for parasites of military relevance.

b. Develop products and conduct clinical trials (vaccines, drugs, and diagnostics) to protect the warfighter from multiple parasites, with a focus on malaria and leishmaniasis.

c. Conduct clinical trials to support FDA clearance and approval of devices, vaccines, and novel candidate drug compounds.

d. Support and train host nation and partners in performing clinical diagnostics and responding to infectious disease outbreaks.

e. Identify novel P. vivax Pre-erythrocyte stage antigens to develop vaccine candidates to protect the warfighter from infection.

f. Develop a chimeric humanized liver model of P. vivax infections to test novel vaccines and drugs.

g. Explore blood stage malaria vaccine candidates and challenge models (models to control rather than prevent infection).

h. Test and evaluate Leishmania rapid diagnostic devices.

i. Perform Malaria and Leishmania surveillance and diagnosis in Peru.

j. Monitor malaria drug resistance in South America.

4.6 Veterinary Services. The contractor shall support the following research objectives:

4.6.1 The Department of Veterinary Services provides consistent and superior care and oversight for all NAMRU-6 research animal use activities in order to ensure maximized production of high-quality research outcomes, while optimizing personnel safety and animal welfare. In addition, maintains a top-tier, Association for Assessment and Accreditation of Lab Animal Care Use (AAALAC)-accredited animal care and use program that meets all DoD mission requirements, sets the standard in Latin America for biomedical research, and enables researchers to succeed at developing life-saving solutions to infectious disease threats affecting U.S. troops and allies. The primary functions are: animal husbandry, Institutional Animal Care Use Committee (IACUC) support and advising, veterinary medical care, training, protocol support, animal health surveillance, protocol consultation, advising, training outside collaborators.

4.6.2 Main objectives:

a. Providing high-quality husbandry and care for all assigned animals.

b. Providing superior veterinary medical and surgical care.

c. Conducting animal health surveillance and quality assurance of the research population

d. Training on animal care and use and research methodologies.

e. Technical assistance with experimental procedures.

f. Advising investigators on proper design of animal use studies.

g. Providing expert advice to the IACUC and the command on animal care & use.

4.6.3 Key assets & capabilities:

a. Animal housing and protocol support at Animal Biosafety Level 1-3s (ABSL) 1-3

b. Capabilities to perform surgical procedures and endoscopy

c. Clinical pathology and necropsy capabilities.

d. Housing and husbandry for Primates, Rodents, and other species as requested by investigators and the IACUC.

4.7 Virology and Emerging Infections Department (VEID). The contractor shall support the following research objectives:

4.7.1 Main research objectives:

a. Characterize the epidemiology and ecology of endemic and emerging viruses.

b. Perform active and passive surveillance of febrile and respiratory diseases throughout Latin America.

c. Conduct exploratory studies of emerging pathogens with emphasis on pathogens emerging from the animal-human interface. Perform active and/or passive surveillance in wild and domestic fauna.

4.7.2 Molecular biology: Molecular tests detecting respiratory, arboviral, hemorrhagic, and enteric infections using the following platforms:

a. Real-Time polymerase chain reaction (PCR-single and multiplex).

b. Conventional PCR.

c. Sanger and next –generation sequencing.

d. Mag-Pix (respiratory, enteric panels).

e. TaqMan array (Viia7).

f. Bioinformatics.

g. Cloning.

4.7.3 Virus isolation for detection of influenza viruses.

a. Cultures in embryoanted eggs

b. Haemagglutination test.

4.7.4 Serology: Immunological tests to identify evidence of past infection using:

a. Plaque Reduction Neutralization Test (PRNT), Elisa, Micro-neutralization (Microneut). Western Blot, Protein determination.

b. Pathogen Discovery: Next-generation sequencing technology and phylogenic analysis on: influenza, dengue, hantavirus, enterovirus, Zika and novel pathogens.

c. Conduct clinical trials for the development of drugs, vaccines and rapid diagnostics tests.

4.8 Research Administration (RAP). The contractor shall support the following research objectives:

4.8.1 The Research Administration Department’s objective is to meet the highest ethical standards in the protection of human research participants and to work with NAMRU-6 leadership and investigators in the identification, development and implementation of tools to ensure such protection.

4.8.2 Follow the ethical mandate of international codes, such as the Belmont Report, the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS). . Policies and procedures comply with the Peruvian Regulation of Clinical Trials – DS 021-2017-SA and Good Clinical Practices of the International Conference for Harmonization, in addition to US DOD, DHHS and FDA policies.

4.8.3 RAP has developed standards for the NAMRU-6 research ethics system for IACUC and IRB to evaluate, approve and provide oversight to the institution’s research portfolio, to educate IRB members, investigators and research staff on their roles and responsibilities and to answer questions from research participants as per national and international regulations.

4.9 Clinical Trial Unit (CTU). The contractor shall support the following research objectives:

4.9.1 Main research Objectives:

a. Conduct epidemiological studies to determine the disease burden of infectious diseases as the way to identify potential locations to conduct clinical trials and/or regulated studies.

b. Conduct vaccine clinical trials to evaluate candidate vaccines of military and global health importance according to Peruvian Law/Regulations and GCP, ICH and U.S. FDA Regulations.

c. Conduct test and evaluation of treatments, medical countermeasures and/or new technologies to enhance the readiness of military personnel. The contractor shall support Phase 2, Phase 3 and Phase 4 trials in support of DOD programs of records and pharma INDs and NDAs for the warfighter benefit.

5.0 LABOR CATEGORIES AND EDUCATION/EXPERIENCE/OTHER REQUIREMENTS AND DUTIES

5.1 General

Task orders issued under the base IDIQ contract may include the labor categories outlined in the table below. The list is a sample and the Government is not limited to these labor categories. The Government’s estimated labor categories are delineated at the task order level.

The Contracting Officer’s Representative reserves the right to review and approve the qualifications of any of the personnel performing or to be performing on this contract.

5.2 Key Personnel

Resumes shall be provided for key personnel, when designated at the task order level.

5.3 Education And Experience Requirements/Duties

5.3.1 Accounting Clerk I

Duties:

- Familiar with standard concepts, practices, and procedures within the accounting field.

- Conforms with and abides by all regulations, policies, work procedures, and instructions.

- Performs data entry to include: posting details of transactions, entering vouchers, and computing and totaling accounts.

- Analyze transactions for conformance with program or agency requirements.

- Performs reconciliations, checks figures, postings and documents to ensure they are correct, mathematically accurate, and properly coded.

-Corrects or notes errors.

- Verifies records of transactions posted by other workers.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 4, English level 3 Minimum Education: Bachelors in Finance.

Minimum Experience: 1 year of finance/accounting experience.

5.3.2 Accounting Clerk II

Duties:

- Possesses advanced expertise in standard concepts, practices, and procedures within the accounting field.

- Performs routine accounting activities such as maintenance of the general ledger, preparation of various accounting statements and financial reports and accounts payable or receivable functions.

- Analyze transactions for conformance with program or agency requirements.

- Relies on experience and judgment to plan and accomplish goals.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 4, English level 3.

Minimum Education: Bachelors in Finance.

Minimum Experience: 2 years’ of finance/accounting experience.

5.3.3 Administrative Assistant I

Duties:

- Oversee all aspects of general office coordination.

- Maintain office calendar to coordinate work flow and meetings.

- Maintain confidentiality in all aspects of customer, staff and agency information.

- Interact with all visitors.

- Answer telephones and transfer to appropriate staff member.

- Open, sort and distribute incoming correspondence, including faxes and email.

- Prepare responses to correspondence containing routine inquiries. Perform supply management for department operations.

- Perform general clerical duties to include, but not limited to, bookkeeping, copying, faxing, mailing and filing.

- May be required to work independently on projects requiring research and preparation of briefing charts and other presentation materials.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 4, English level 3.

Minimum Education: High School Diploma Minimum Experience: Two years of experience.

5.3.4 Administrative Assistant II

Duties:

- Oversee all aspects of general office coordination.

- Maintain office calendar to coordinate work flow and meetings.

- Maintain confidentiality in all aspects of staff and agency information.

- Interact with visitors.

- Answer telephones and transfer to appropriate staff member.

- Open, sort and distribute incoming correspondence, including faxes and email. Prepare responses to correspondence containing routine inquiries.

- . Track supplies in support of department operations.

- Perform general clerical duties to include, but not limited to, bookkeeping, copying, faxing, mailing and filing.

- Will provide administrative support to department staff with office management responsibilities to include budgeting, preparing reports, recordkeeping and document translation.

- May be required to work independently on projects requiring research and preparation of briefing charts and other presentation materials.

- Assist military and civilian staff with their travel request (TDY request, reservations, etc.).

Minimum Education/Experience/Other Requirements:

Language: Spanish level 4, English level 3.

Minimum Education: High School Diploma.

Minimum Experience: Four years of experience.

5.3.5 Administrative Assistant III

Duties:

- Perform secretarial and other administrative services for study site to ensure efficient operations of the study site office.

- With Government approval, provides support for Government employee in the tracking and accounting of the cash flow (from the IDIQ contract) of the study site (petty cash, book keeping and cost control). Provides assistance to the Government employee in the submission and reconciliation of the expense reports.

- Maintain confidentiality in all aspects of staff and agency information.

- Provides support for the Government employee who executes Human Resources duties for the site study, such as control of staff attendance and payroll, staff queries and orientation. Provides assistance to Government employee who maintains personal records and training records of the staff and ensures that these documents/records are up to date.

- Answer telephones and transfer to appropriate study site staff member.

- Manage large volumes of documentation in an accurate manner in accordance with protocol safeguards.

- Provides support in the purchase and maintenance of laboratory and office materials and supplies as needed.

- Perform general clerical duties to include, but not limited to, bookkeeping, copying, faxing, mailing and filing.

- Prepare letters, memos, reports, and administrative notices, etc., as required.

- With Government approval, develop and maintain a filing system.

- Provides support in the followup on deliveries and shipments.

- Generate a report of all study site activities to NAMRU6 Principal Investigator.

- Provides logistical support for the study and other admin activities as assigned by the coordinator.

Minimum Education/Experience/Other Requirements:

Minimum Education: Bachelor’s degree or equivalent technical degree.

Language: Spanish level 4, English level 2.

Minimum Experience: At least five years of experience in the field or related area.

Technical Skills:

- Strong organizational and planning skills.

- Good attention to detail and problem solving skills.

5.3.6 Biologist

Duties:

- Provides professional services as a biologist with expertise in morphological and biological identification of mammals and/or birds.

- Mammalogy Tasks: Determines the diversity of mammals existing in the assessment area using live capture traps, and generates a detailed database of the mammals captured in the evaluation area.

- Ornithology Tasks: Identifies bird species from distance and have a photographic record to link evidence of species. Takes environmental fecal samples of birds identified with UTM swabs. Generates a detailed database of the birds identified in each field site.

- Takes the biometric data of each of the captured specimens. Identifies the important species or flag species and their categorization according to national legislation Decreto Supremo No. 004-2014 Ministerio de Agricultura y Riego. (D.S. N ° 004-2014-MINAGRI), and international legislation Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) and International Union for Conservation of Nature IUCN).

- Recognizes current threats and establishes proposals for conservation.

Minimum Education/Experience/Other Requirements:

Minimum Education: Biologist bachelor degree with expertise in Mammalogy and/or Ornithology.

Minimum Experience: 1 year in research studies or field studies.

Language: Spanish level 4, English level 2.

5.3.7 Biostatistician

Duties:

- Independently performs a variety of research and analysis tasks and may provide training and technical supervision to less experienced staff.

- Collects, compiles, validates, interprets and analyzes data and trends using standard practices and techniques in the field(s) of specialization.

- Performs simple to moderately complex statistical modeling using standard software packages.

- Applies quantitative and/or qualitative analysis techniques and methods.

- Works on assignments that are moderately complex under indirect supervision.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 4, English level 3.

Minimum Education: Bachelors in Statistics, mathematics, epidemiology, or associated disciplines.

Minimum Experience: 1 year experience conducting biostatistical analyses in a health research/services environment.

5.3.8 Cloud Systems Engineer I

Duties:

- Supports Risk Management Framework (RMF) implementation for DoD IT and the transition of locally hosted applications to a cloud environment.

- Determines feasibility of requested software applications for cloud hosting, hybrid hosting or managed services as a tenant in the IPN.

- Supports the planning, coordination, and accomplishment of application testing to identify need for application changes before products move from development into production environments.

- Supports the determination/identification of specifications, equipment, and hardware environments necessary to analyze, evaluate, and deploy software applications, as required. Supports the conduct of tests to identify the need for application changes before products move from development into production environments.

- Supports the determination/identification of specifications, equipment, and hardware environments necessary to analyze, evaluate, and deploy software applications, as required.

- Serves as a subject matter expert for assisting IT customers with common services to the cloud and serves as a point of contact for application owners for instructions on how to transition current applications to Department of Defense (DoD) approved cloud storage environments.

Minimum Education/Experience/Other Requirements:

Citizenship: US citizen required Language: English level 4.

Minimum Education: BS in Computer Science or Engineering or Technical degree with focus in Microsoft Certified Systems Engineering-MCSE, Cisco Certified Network Associate-CCNA, or similar.

Minimum Experience: 2 years of progressively responsible, job-related, professional level experience.

Clearance: Secret/T3 required.

5.3.9 Cloud Systems Engineer II

Duties:

- Subject to government approval, supports the development and delivery of Biomedical Informatics Department's cloud computing based software solutions.

- Collaborates with the rest of the engineering team on the various layers of the infrastructure for BID's software product solutions.

- Setup, support and troubleshoot cloud computing services and software solutions in cloud environments.

- Design, implement, develop and deliver cloud computing software solutions.

- Build robust and scalable applications information system architectures, based on cloud computing services, platforms and open-source technologies.

- Writes, reviews, tests, refactors, tunes and optimize software applications’ code for cloud computing environments.

- Prepare and maintain technical documents of best practices, procedures and standards for application and information systems under cloud computing environments.

- Researches, identifies, develops, and tests new approaches to application development based on cloud computing services and environments.

Minimum Education/Experience/Other Requirements:

Education: BS degree in computer science, software engineering, or technical degree in an equivalent technical discipline.

Relevant certification on cloud computing or equivalent.

Experience/ Job Knowledge:

- Two or more years’ experience as Cloud System Engineer, Cloud Developer or equivalent.

- Two or more years' experience in software development.

- Proficiency in cloud computing services and solutions (i.e. IaaS, PaaS, SaaS, etc.).

- Hands-on experience designing, implementing, developing and deploying software solutions into cloud computing environments (e.g. AWS, Google Cloud and/or Azure).

- Experience in open-source technologies, software development, scripting languages, systems engineering and multiple cloud computing provider environments.

- Knowledge of programming languages including Java, PHP, Python or R.

- SQL (PostgreSQL) and non-SQL (MongoDB) database systems, Querys.

- Solid knowledge of virtualization and container tools (i.e. Docker).

- Experience in DevOps tools: Continuous Integration /Continuous Deployment.

(CI/CD), automated testing, code quality and security analyzers.

Language: English level 2.

Clearance: Secret/T3 required.

5.3.10 Data Entry I

Duties:

- Work from various source documents that may have been coded and that may require additional selecting, coding, or interpreting of data to be entered. Such work may require the application of experience and judgement in selecting procedures to be followed and in searching for, interpreting, selecting, or coding items to be entered from a variety of source documents.

- Operates keyboard controlled data entry device to transcribe data into a form suitable for computer processing. - -- - Operates word processing equipment to compile, type, revise, combine, edit, print and store documents. Reads instructions accompanying material, or follows verbal instructions to determine format and content required. - Checks completed document on screen for errors. Proofreads and edits document for grammar, spelling, punctuation and format. This work may also include hand correcting of data entry information.

- Verify or perform work involved in abstracting and/or coding information from schedules, questionnaires, reports, documents, and other written or printed material according to instructions and related codes involving words, numerical and alphabetical symbols. Work may entail formatting source material into documents such as reports, conference materials, or presentation handouts. As part of the process of handling the materials involved in data to be entered and maintained in computer files, this position may involve: scanning, opening, sorting, marking, tabulating, and filing various documents.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 3, English level 1.

Minimum Education: 2 years of Technical studies in data management or Associate of Arts degree or equivalent.

Minimum Experience: 1 year with data entry/ verification experience, preferably in research setting.

5.3.11 Data Entry II

Duties:

- Enter all data in physical science forms into databases designed and managed by NAMRU-6. Scan such forms and store them electronically following NAMRU-6 naming convention and specifications.

- Perform data entry services by converting physical information in scientific data collection forms into electronic format in databases stored in the NAMRU-6 network.

- Perform storage and labeling of boxes with scientific data collection forms

- Perform cleaning and maintenance of scientific data collection forms to allow clear reading and scanning.

Minimum Education/Experience/Other Requirements:

Language: Spanish level 3, English level 1.

Minimum Education: Completion of High School.

Minimum Experience: 3 years in data entry services.

5.3.12 Field Worker

Duties:

- Provide basic support to prospective cohort human research studies by supporting numerous study administrative and logistical requirements.

- Duties include: setting up study sites and transporting/moving equipment and supplies.

- Identify potential study participants.

- Enroll human subjects.

- Present themselves professionally and correctly convey the study forms and consents to study participants. - -------- Execute study activities in accordance with all ethics regulations for the management of personal information.

- Perform visits weekly with study participants, collect clinical information by completing case report forms and obtaining clinical samples in accordance with the study protocols.

- Collect biological specimens (blood, saliva, urine, etc.) in accordance with the study protocols and transport the specimens back to the laboratory.

Minimum Education/Experience/Other Requirements:

Minimum Education Level: Technical degree in health sciences (e.g.