US NAMRU SOUTH RECOMPETE BASE PWS_DRAFT.docx

U.S. NAVAL MEDICAL RESEARCH UNIT SOUTH - 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 U.S. Naval Medical Research Unit SOUTH (NAMRU SOUTH) mission is to ensure the operational readiness and health of U.S. Service members and our Peruvian national partners through health sciences research, infectious disease surveillance, medical countermeasure testing and evaluation, and health security cooperation. We will strive for excellence in accomplishing our mission and continue building upon our stellar reputation not only as the U.S. Naval's premier and largest oversea laboratory, but also as the United States of America's front-line scientific ambassadors to Central and South America.

The vision of NAMRU SOUTH is to enhance the bio-security of the United States and the Region by detecting diseases of military and public health significance throughout the U.S. Southern Command area of responsibility. This action is accomplished through the use of epidemiologic research studies and strengthening of partner nations' disease surveillance activities along with the development and testing of new strategies and products, including diagnostics, medicines, vaccines, and vector control measures, to mitigate bio-security threats.

NAMRU SOUTH conducts research studies in support of the readiness and Force Health Protection (FHP) of US military personnel. In addition, NAMRU SOUTH 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 SOUTH 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 (SOUTHCOM) area of responsibility.

NAMRU SOUTH ensures that, when feasible, host nation investigators are included in the planning, performance, and publication of NAMRU SOUTH 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 SOUTH.

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).

2.4 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).

2.5 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.

2.6 To comply with federal mandates for time-to-hire, contractors should note the DoD security clearance process, whereby all labor categories performing under task orders issued under the base contract require a background investigation in accordance with DODI 5200.02 and DODI 1000.13; while a facility level clearance is not required, contractors accessing classified information must obtain a Personnel Security Clearance (PCL), with the level (Confidential, Secret, or Top Secret) determined by the information's sensitivity, and requiring Key Management Personnel (KMP) to also undergo PCL reviews as part of the Facility Security Clearance (FCL) process; contractors needing government computer system access (Common Access Card/CAC) must be fingerprinted, with the exact security levels defined at the task order level; achieving the goal of under 80 days to hire hinges on contractors providing complete and accurate documentation to expedite the clearance process.

The Contractor will be responsible for conducting the personnel clearance necessary to meet DoD standards.

2.7 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.

2.8 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).

2.9 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.

2.10 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 Department of Defense (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, DHHS Office of Laboratory Animal Welfare (OLAW) assurance, and United States Department of Agriculture (USDA) site inspections.

2.11 Travel is expected in support of the research efforts at NAMRU SOUTH. Travel approval must be processed in accordance with NAMRU SOUTH 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.

2.12 Other Direct Costs (ODC) are expected in support of the research efforts at NAMRU SOUTH. ODCs may include equipment, research supplies, scientific meeting registration, services and other costs that will accomplish the mission objectives such as U.S. Food and Drug Administration (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.

2.13 Subcontracts: Subcontracts are expected in support of the research efforts at NAMRU SOUTH. 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).

2.14 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.”

2.15 The Government estimates a full time equivalent (FTE) at 1912 hours (One FTE = 1912 hours (2080 hours – 88 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.

2.16 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 SOUTH’s instruction. If contractor use of GSA Fleet vehicles is allowable under NAMRU SOUTH’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).

2.17 Work Location and Schedule: NAMRU SOUTH is headquartered in Lima, Peru with a Naval Laboratory in Iquitos (Loreto), Peru, a satellite laboratory at U.S. Joint Task Force-Bravo (JTF-B) Soto Cano Air Force Base in Comayagua, Honduras.

Other locations within SOUTHCOM may require research support services. The exact locations within this area of responsibility 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 SOUTH COR and approved by the NAVSUP 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.

2.18 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, Iquitos, Peru and JTF-B, Honduras. 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 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.

2.19 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.

If NAMRU SOUTH 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.

2.20 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 SOUTH 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.

2.21 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 can conduct 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.

2.22 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 all liability caused by the acts or omissions of its agents or personnel. The contractor will assume all responsibility and liability for 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 SOUTH 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 SOUTH departments:

Scientific Departments: Bacteriology, Entomology, Parasitology, Veterinary Services, Virology, Clinical Trials Department, and Research Administration Program.

Support Departments and Programs: Command Suite, Directorate for Administration, Engineering and Facilities, Information Management/Information Technology, and Safety, and Occupational Health and Environmental (SOHE) Department.

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 SOUTH sites in Iquitos and Lima and at other specified locations, NAMRU SOUTH 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 bio-surveillance 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 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. Enteric Disease surveillance and pathogen characterization.

b. Drug/Therapeutics/Intervention testing: Preclinical development of novel prophylaxis and/or treatment 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 wound infections.

e. Waste-water surveillance efforts for bacterial pathogens and antimicrobial resistance markers.

f. Use of bacteriophages as therapeutics.

g. Provide support on various laboratory techniques following Standard Operating Procedures.

4.2.2 Diagnostic assay development:

a. Antigen discovery for development of rapid field test for pathogenic bacteria in clinical and environmental sources.

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

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

4.3.1 Main research objectives:

a. Development support for malaria and dengue therapeutics through experimental mosquito infection models.

b. Vector competence studies in mosquitoes.

c. Testing and development of topical and spatial repellents, and novel vector control tools for protection of forward deployed troops in the SOUTHCOM area of responsibility (AOR).

d. Targeted surveillance of arthropod vectors and arthropod-borne pathogens in Peru and across SOUTHCOM AOR to identify vector-borne disease threats, inform force health protection, and develop real-time risk models for control of vector-borne pathogens.

e. Monitor insecticide resistance in mosquito vectors in Peru and across SOUTHCOM AOR,

f. Provide support on various field and laboratory entomological techniques following Standard Operating Procedures.

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

4.4.1 Main research objectives:

a. Conduct disease surveillance for parasites of military relevance.

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

c. Identify novel Plasmodium Pre-erythrocyte stage antigens to develop vaccine candidates to protect the warfighter from infection.

d. Develop new infection models to test novel vaccines and drugs for tropical diseases.

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

f. Test and evaluate diagnostic devices and treatments for tropical diseases.

g. Perform Malaria, Leishmania, and Chagas surveillance and detection in SOUTHCOM.

h. Monitor malaria drug resistance in SOUTHCOM.

i. Provide support on various laboratory techniques following Standard Operating Procedures.

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

4.5.1 The Department of Veterinary Services provides consistent and superior care and oversight for all NAMRU SOUTH 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.

4.5.2 Main research objectives:

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

b. Provide superior veterinary medical and surgical care.

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

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

e. Technical assistance with experimental procedures.

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

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

h. Provide support on various laboratory techniques following Standard Operating Procedures.

4.6 Virology . The contractor shall support the following research objectives:

4.6.1 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 both in human and animal (wild and domestic) population.

c. Conduct exploratory studies of emerging pathogens with emphasis on pathogens emerging from the animal-human interface.

d. Conduct surveillance using a mobile unit equipped with advanced analytical tools.

e. Perform wastewater-based bio-surveillance of pathogens throughout SOUTHCOM.

f. Evaluate point-of care platforms for early detection of viral and emerging agents to enhance the readiness of military personnel.

g. Provide support on various laboratory techniques following Standard Operating Procedures.

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

4.7.1 Main objectives:

a. Meet the highest ethical standards in the protection of human research participants.

b. Work with NAMRU SOUTH leadership and investigators in the identification, development and implementation of tools to ensure such protection for human research participants.

c. 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 DoD, DHHS, and FDA policies.

d. Develop standards for the NAMRU SOUTH research ethics system for IACUC and Institutional Review Board (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.

e. Support epidemiological and clinical studies conducted by the various Science Departments at NAMRU SOUTH.

4.8 Clinical Trials Department (CTD). The contractor shall support the following research objectives:

4.8.1 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 FDA Regulations.

c. Conduct test and evaluation of treatments, prophylaxis, medical countermeasures and/or new technologies as well as non-pharmacological interventions 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.

d. Coordinate necessary activities with the science departments.

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.

Contractors will follow same occupational health guidelines and requirements as civilian and military counterparts OR something like Contractors will complete all annual DoD safety, biosafety trainings and Occupational Health requirements.

Role-Specific Activities to be defined per assignment. Key personnel shall provide resumes, when designated at the task order level. All duties subject to Government approval.

5.2 Administrative Assistant I

Duties:

- Oversee all aspects of general office coordination.

- Maintain confidentiality in all aspects of customer, 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.

- Perform supply management for department operations.

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

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

Minimum Education: Completed Associate’s coursework or equivalent coursework Minimum Experience: Two years of experience Language: Spanish level 4, English level 3

5.3 Administrative Assistant II

Duties in addition to Administrative Assistant I:

- Track supplies in support of department operations.

- Will provide administrative support to department staff with office management responsibilities to include but not limited to budgeting, preparing reports, recordkeeping and document translation.

- Assist with documentation collection for contract close outs.

Minimum Education: Associate’s degree or equivalent degree Minimum Experience: Three years of experience Language: Spanish level 4, English level 3

5.4 Administrative Assistant III

Duties in addition to Administrative Assistant II:

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

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

- Assist in maintaining training records.

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

- Assist with translation of documentation between Spanish and English.

- Assist with order follow ups and tracking orders, shipments, and inventory.

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

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

Minimum Education: Bachelor’s degree or equivalent degree Minimum Experience: At least five years of experience in the field or related area.

Language: Spanish level 4, English level 4

5.5 Data Entry I

Duties:

- Scan forms and store them electronically following NAMRU SOUTH 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 SOUTH 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: Completion of High School Minimum Experience: Six months in data entry services Language: Spanish level 3, English level 1

5.6 Data Entry II

Duties in addition to Data Entry I:

- Work from various source documents that may have been coded and may require additional selecting, coding, or interpreting of data to be entered.

- Create electronic interfaces to perform data entry into electronic databases

- Operate keyboard-controlled data entry device to transcribe data into a form suitable for computer processing.

- Operate word processing equipment to compile, type, revise, combine, edit, print and store documents.

- Check completed document on screen for errors (edit document for grammar, spelling, punctuation, and formatting).

Minimum Education: 2 years of technical studies in data management or Completed Associate’s coursework or equivalent completion Minimum Experience: 1 year with data entry/verification experience, preferably in research setting Language: Spanish level 3, English level 1

5.7 Information Technology Assistant

Duties:

- Perform physical installation and deployment of IT hardware, including but not limited to computers, printers, multifunctional devices (MFDs), scanners, monitors, TVs, etc.

- Perform a full inventory of IT assets, verifying ECN numbers, serial numbers, brand and model, physical location and person assigned to. Provide inventory in Excel spreadsheet format.

- Receive hardware ordered by the IT department and store it in the IT office and/or IT warehouse space.

- Replace supplies required to MFDs and printers in the Command.

- Support events organized by the Command by installing the audio/video portable system where the event is going to take place.

- Support the DRMO process by removing hard disks from computers, locating hardware in the DRMO assigned space, and control the list of assets in the DRMO process.

- Support the IT personnel in IT activities that do not require system or network administration roles or access, to include Microsoft Office and Windows usage, data transfer from laboratory equipment to network, etc.

Minimum Education: 3 years studies in computer science or related, or 1-year technical degree in computer science or related.

Minimum Experience: One year of experience in any IT field Language: Spanish level 4, English level 1

5.8 Laboratory Animal Caretaker

Duties:

- Provide daily care of laboratory animals, including nonhuman primates and rodents in safe and sanitary manner according to established guidelines and procedures as outlined in the "Guide for the Care of Use of Laboratory Animals" National Research Council (NRC) 8th Edition.

- Maintain continuous high-quality standards in animal husbandry, veterinary care, and research practices as stablished from a Biomedical AAALAC Accredited Animal Research Facility.

- Record daily activities and daily environmental parameters.

Minimum Education: High school diploma Minimum Experience: 4 years of experience handling and caring for animals, preferably laboratory animal species in a clinical or research laboratory setting.

Basic computer skills: Microsoft knowledge (word, excel and power point) Language: Spanish level 3, English level 2

5.9 Field Worker Aide

Duties:

- Assist with mosquito, sand fly and biting midge trapping or protected human landing catch under supervision.

- Condition and transport samples from the field to the laboratory and assist in sorting samples under supervision.

- Help prepare materials, supplies, and tools for field activities.

- Complete simple data forms and ensure proper labeling and documentation of entomological samples.

- Carry out simple manual labor tasks such as moving materials or cleaning equipment.

Minimum Education: Completion of primary school Minimum Experience: At least 1 year of relevant work experience Language: Spanish Level 2, No English required

5.10 Field Worker I

Duties in addition to Field Worker Aide:

- Provides general operational support to field and research studies.

- Responsible for logistical setup, sample handling, participant coordination, and other routine tasks (such as set up study sites, move equipment, and supplies).

- Assist in identifying and organizing study participants.

- Conduct basic data entry and maintain simple records.

- Conduct regular visits to households or community locations to collect data, complete study forms, and obtain clinical (e.g., blood draws, saliva, etc.) or entomological (e.g., mosquitoes) samples.

- Complete simple data forms and ensure proper labeling and documentation of samples and activities.

- Assist in behavioral and environmental experiments.

- Maintain cleanliness in assigned workspaces and labs.

- Support warehouse or supply logistics.

Minimum Education: Completion of secondary school Preferred: Technical degree in health sciences (e.g., nursing technician, laboratory technician) for roles involving clinical tasks.

Minimum Experience: At least 1 year of relevant work experience Language: Spanish Level 2, English 1

5.11 Field Worker II

Duties in addition to Field Worker I:

- Perform skilled tasks in support of research studies, including technical assistance, biosafety compliance, and coordination activities.

- Perform all tasks described under Field Worker I with greater autonomy.- Handle and prepare contaminated materials for sterilization and safe removal.

- Assist with monthly safety inspections (e.g., fire extinguishers, AEDs, eyewash stations).

- Support maintenance and minor repairs of laboratory equipment.

- Coordinate with couriers (with supervisor approval) for study-related deliveries.

- Assist in receiving and organizing materials and supplies.

- Ensure proper documentation and adherence to biosafety and ethical standards.

Minimum Education: Completion of a technical degree Minimum Experience: Three years of field or laboratory support experience.

Language: Spanish Level 3, English 1

5.12 Laboratory Technician Aide

Duties:

- Incumbent will support all the activities of NAMRU SOUTH studies conducted at NAMRU SOUTH or in various field sites.

- Participate in laboratory experiments including rapid tests or insecticide testing.

- Perform essential daily lab duties such as preparing samples, setting up and maintaining equipment, keeping the lab clean and organized, manage supplies, and perform routine tests under supervision and following Standard Operating Procedures (SOPs).

- Responsible for following all safety procedures, guidelines, and regulations to ensure a safe and healthy working environment.

- Receive, record, aliquot, label, and process samples. As applicable, assist in shipment or transportation of samples and/or specimens from the field sites via acceptable cold chain conditions to the laboratory for analysis and testing.

- Record and organize laboratory data and report results on a regular basis.

- Work rotating shifts, if needed, to include days, evenings, nights, and weekend and be available to travel to different regions for study activities as required.

- As applicable, participate in the rearing of insect colonies.

- Participate in laboratory experiments using specialized procedures.

Minimum Educational: Technical degree in phlebotomy, nursing and/or laboratory services or certified laboratory technician Minimum Experience: 1 year of experience working in laboratory procedures related to research and handling of biological samples (storage, biosafety) Language: Spanish level 3, English level 1

5.13 Laboratory Technician I

Duties in addition to Laboratory Technician Aide:

- Conduct regular visits to households or community locations to collect data, complete study forms, and obtain clinical (e.g., blood draws, saliva, etc.) or entomological (e.g., mosquitoes) samples.

Responsible for proper functioning and performance of laboratory and laboratory assays, to include, but not limited to, receipt and logging of biological samples, proper execution of laboratory standard operating procedures and quality assurance.

- Responsible for process, test, and characterize various types of samples including but not limited to blood, serum, swabs, fecal, mosquitos, tissues, using a variety of laboratory techniques as needed or required.

- Follow all proper standards and requirements of safety, biosafety, and occupational health during all aspects of laboratory work. Ensures laboratory space meet standards of safety, biosafety, and occupational health; ensures section-related deficiencies are mitigated in due time.

- Complete require annual proficiency test.

- Maintain an updated logbook of all activities pertaining to the study samples.

- Participate in laboratory experiments using specialized procedures.

- Ability to prepare reports of laboratory results within section to be delivered for quality control.

Minimum Education: Associate degree (in Biology, Laboratory Technology or Medical Technology) or equivalent degree Minimum Experience: 2 years Other Requirements: Basic mathematical and chemistry knowledge as well as mechanical abilities required to fulfill laboratory procedures, basic knowledge of laboratory procedures and safety/biosafety, basic knowledge of data and sample management, basic knowledge of Microsoft Office programs.

Language: Spanish Level 4, English Level 2

5.14 Laboratory Technician II

Duties in addition to Laboratory Technician II:

- Responsible for maintaining up to date all proficiency for all test performed and batch production records for all in house prepared materials including but not limited to positive controls, antigens, antibodies, among others

- Prepare proficiency testing panels and assign to co-workers and reagents cross testing.

- Maintenance of the reagent (chemical and biological) inventories, preparation of reagents, standardization and validation of new tests, training collaborators, visitors, and students.

- Keep laboratory database and records managements updated.

- Prepare and update Standard Operating procedures.

- Records sample/specimen/test information such as test results, type of test, observations and laboratory activities.

- Perform laboratory assays at NAMRU SOUTH facilities or at NAMRU SOUTH partner/collaborator’s facilities as required.

- Analyze data, produce reports and/or presentations of results, and assist in manuscript writing.

Minimum Education/Experience/Other Requirements:

Minimum Educational: Associate degree (in Biology, Medical Technology or Laboratory Technology) or equivalent degree Minimum Experience: Three years managing the implementation of laboratory protocols and performing quality control of laboratory procedures and managing implementation of new laboratory protocols.

Basic knowledge of laboratory procedures, data and sample management, Microsoft Office programs, and in-depth knowledge of laboratory techniques.

Language: Spanish level 4, English level 2

5.15 Nurse Aide

Duties:

- Working with or without supervision at a health center or in the field sites (community).

- Identify potential participants, enroll participants, provide informed consents/assent and study questionnaires following ethical research guidelines.

- Obtain appropriate medical information from patients, maintain records and data base (as needed) all while maintaining confidentiality.

- Responsible for conducting telephone calls, follow-ups, and/or home visits, maintain communication with hospital departments.

- Responsible for carrying out nursing procedures, labeling and transporting samples via standard acceptable cold chain conditions to the laboratory for analysis and testing.

- Perform phlebotomy procedures (i.e. venipuncture, vital signs monitoring, etc.).

- Perform quality control and verification of study documents in accordance with the protocol.

- Administer specific medications (such as topical creams, subcutaneous lidocaine, etc.) in accordance with the study protocols.

- Report progress on assignments on a regular basis to primary supervisor and secondary supervisor.

- Provide administrative and logistic support (supplies, transportation, etc.) for the execution of study protocols.

- Work with the laboratory staff, may be responsible for collecting, handling, aliquoting, storage and shipping of biological samples (i.e. blood, serum, etc.).

- Perform inventories for fieldwork and laboratory supplies and reagents, including office and laboratory equipment in use.

- Ability to work rotating shifts, to include mornings, afternoons, evenings, nights and weekend as required.

Minimum Education: Technical degree in phlebotomy, nursing and/or laboratory services.

Minimum Experience: At least 1 year experience working in research (consent form application, biosafety and ethics). 1 year experience working at health centers, preferred. 1 year experience with handling and processing biological samples (storage, cold chain, biosecurity).

Language: Spanish level 4, English level 1 Technical Skills: Computer skills (Microsoft Office); Good organizational skills

5.16 Nurse I

Duties in addition to Nurse Aide:

- Develop, standardize, and train research personnel (in the hospital or in the field sites).

- Coordinate/organize daily tasks at field sites or at hospital sites.

- Ensure that contractor nurse aides adhere to international ethical standard and good clinical practices.

- Coordinate the activities of contractors who maintain sample records collected and tested.

- Perform quality control verification of study documents such as consents, data collection sheets, microscopy result forms, etc.

- Coordinate the activities of contractors who perform follow-ups and maintain database containing results obtained from the study.

- Write and develop study reports (weekly, quarterly, or annually) as required by department projects.

- Assist research investigators in the preparation of reports, oral presentations of materials related to specific research projects assigned.

- Assist the research investigator or project coordinator in the preparation of budgets, protocol amendments, and work schedules in support of research projects.

- Administer medication, setting IVs, injections, updating subject records, provide emotional support, and subject education.

Minimum Education: Nursing or Midwife degree Minimum Experience: 2 years minimum experience working in research (administration of consent, previous work at a hospital preferred, previous experience in supervisory role).

Language: Spanish level 4, English level 2

5.17 Nurse II

Duties in addition to Nurse I duties:

- Serve as a lead or mentor for Nurse I and Nurse Aide staff, providing guidance and advanced training.

- Take a primary role in the development, writing, and implementation of new research protocols, including study design and methodology.

- Conduct advanced data analysis and interpretation of research results for publications and presentations.

- Act as a subject matter expert on human subject protection, ensuring all research activities comply with institutional and international regulatory and ethical standards.

- Present research findings at internal meetings and potentially at external conferences or symposiums.

- Perform advanced or specialized clinical assessments and procedures as required by specific research protocols.

- Oversee and manage multi-site study coordination, ensuring consistency and quality across all locations.

- If engaged in occupational health program activities, provide occupational health nursing services and support for the occupational health program, such as:

- Be certified in Basic Life Support (BLS) and First Aid.

- Support the institution’s blood borne pathogen and tuberculosis control program.

- Support for the contact tracing and monitoring of infectious disease in the workplace.

Minimum Education: Nursing or Midwife degree Minimum Experience: 3 years minimum experience working in occupational health (performing medical surveillance; executing occupational health program).

Language: Spanish level 4, English level 3 Technical: Trained and certified to give Basic Life Support (BLS) and First Aid Training

5.18 Program Manager

Duties:

- Facilitate information flow between the COR, the contractor, and contract personnel.

- Oversee the onboarding of contractor personnel and serve as a key resource for all contract personnel.

- Provide on-site administrative oversight of contract personnel, to include pay, promotions, leave, work hours, conflict resolution, and disciplinary actions.

- Identify and evaluate problems affecting…