Attachment 5- Labor Category Descriptions.pdf

LABOR

CATEGORIES DESCRIPTION LANGUAGE

REQUIREMENT PROFESSIONAL EDUCATION

Onsite lead. Responsible for the technical oversight and management of the Science Team (PI’s, Technicians, field personnel, and regulatory personnel). Works with the COR and Senior scientist to establish and oversee scientific priorities of work in the laboratory. Verifies and works with team members to ensure contractor compliance with cost, schedule, and performance parameters as established in the PWS, QASP, & project proposals-in accordance with COR guidance. Provides first line management and guidance to all contract personnel on site including both technical and professional performance and behaviors. Supports research oversight and program development requirements where contract personnel may be involved assisting with all aspects of site and partnership development.

Ph.D. in microbiology, molecular biology, or equivalent from a college or university accredited by the US or their national authority required. Documented experience in bacteriology or virology required.

Supervises a diverse team of investigators and technicians to generate knowledge products in accordance with government direction to mission requirements.

Demonstrated experience developing and managing infectious disease or vector research projects and/or clinical research or surviellance protocols required.

Demonstrates knowledge and proficiency with Human Subjects protection animal-use, and/or regulatory oversight requirement management.

Documented experience with biomedical research project / programmatic management; and Science & Technology (S&T) management; either ( Defense Acquisition University (DAU) / DAIWA S&T Management Level 2 (3 preffered) or national equivalent orDAU Project Manager Level 2 (preferred) / Project Management Professional (or national equivalent)

Documented experience performing bacterial or viral culture and/or antimicrobial susceptibility techniques required.

ATTACHMENT 5

Research Program Manager

Demonstrated English language proficiency as Level B2 English required, Level C1 preferred. Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English.

Supports initiation or modification of research proposal / agreement / human or animal use documentation (see Human Subjects Protection Advisor and Business Agreement Specialist) for submission through WRAIR business process and other local/national regulatory bodies, as necessary. Ensures timely proposal review, editing, and submissions in compliance with all applicable WRAIR processes, US/country laws, regulations, policies, procedures, and guidelines. Responsible for interviewing, hiring, and training contractor employees. Responsible for staff development, planning, assigning and directing work. Responsible for addressing complaints and resolving problems.

Demonstrates proficiency with developing and maintaining research proposals, standard operating procedures (SOPs), and other knowledge products (e.g., reports, abstracts, presentations).

REQUIREMENT PROFESSIONAL EDUCATION

Leadership and business management experience with comprehensive knowledge of business processes, accounting, analytical skills, and project management. Supervises and directs a staff

Adequate education, experience, and certifications to provide resource management and human resources support. Must have the ability and proficiency required to interpret, process, manipulate and communicate financial data in MS Outlook, Word, Excel, Power Point or similar programs.

Provides guidance to the Director on strategic communication and engagement with host nation partners, Government officials, and other host nation dignitaries.

Documented experience with project / programmatic management in particular in a biomedical Science & Technology research environment. Has an equivalent training/certification at minimum of Defense Acquisition University / DAIWA Project Management Level 1 or host nation equivalent.

Experience managing the activities of a group, organizational ability to direct multiple activities of a group, organizational and business process improvement staff to execute the business plans, developing plans and projects, determining needs, investigating and resolving problems, interfacing with other functions and outside personnel, preparing capital and operating requests, and managing staff. Should be able to act as senior resource for a specific discipline or function. Ability to organize and direct work, coordinate efforts with other functions, and direct personnel to achieve objectives. Directly supervises contractor employees. Must be capable of obtaining a CAC.

Medical degree from a college or university accredited by the US or their national authority. Will have successfully completed the appropriate residency(s)/fellowship(s) and be board certified in the required specialty(s)/sub-specialty(s). A trained physician or Nurse with a high level of expertise gained by extensive study and practice in the area of infectious diseases, preventive medicine, internal medicine, clinical immunology or other related field. Physicians / Nurses will be licensed in their country/state/province by their national accrediting body. Alternately, a Ph.D. in microbiology, molecular biology, or equivalent from a college or university accredited by the US or their national authority preferred.

Demonstrated experience developing and managing research protocols required with emphasis on clinical observational trials and infectious disease surveillance

Competitive candidates will demonstrate experience with developing and maintaining funding proposals, research protocols, standard operating procedures (SOPs), and other knowledge products (e.g., reports, abstracts, presentations).

Program and Resource Manager

Demonstrated English language proficiency as Level B2 English required, Level C1 preferred. Demonstrated proficiency to write and review correspondence, take oral/written instructions, keep records, and discuss procedures in English. Native Georgian speaker or demonstrated Georgian language proficiency as Level B2 Georgian required.

Clinical Research Principle Investigator

Responsible for protocol development, submission, management and execution of human and nonhuman-subjects clinical research studies. Responsible for executing clinical research trials adhering to good clinical (GAP) and all applicable ethical and regulatory requirements. Interaction as a member of a team of scientists, clinicians, and technicians responsible for resourcing, executing, analyzing data, and publishing research. Responsible for developing infectious disease surveillance and research program aims and goals. Responsible for developing and updating infectious disease surveillance and research program protocols, research support documents, research relevant standard operating procedures, and support and initiative for laboratory grant writing efforts. Will be required to assist in developing, implementing, and executing training programs for new clinical research personnel... Interact as a member of a collaborative team in the Georgian scientific community.

Demonstrated English language proficiency as Level B2 English required, Level C1 preferred. Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation (e.g., Georgian, Bulgaria, Poland, Latvia, etc.) required.

REQUIREMENT PROFESSIONAL EDUCATION

Responsible for research and clinical surviellance project development and human or animal use protocol development, submission, management and execution.

Ph.D. in microbiology, molecular biology, or equivalent from a college or university accredited by the US or their national authority required; performing molecular laboratory techniques required. Documented experience in bacteriology or virology required.

Responsible for assessing, selecting, and implementing technology in the areas of bacteriology, virology, immunology, and/or molecular biology. Interaction as a member of a team of scientists, clinicians, and technicians responsible for resourcing, executing, analyzing data, and publishing the research. Responsible for developing infectious disease surveillance and research project aims and goals. Responsible for developing and updating infectious disease surveillance and research project protocols, research support documents, research relevant standard operating procedures, and support and initiative for laboratory proposal writing efforts.

Responsible for developing and implementing training programs. Responsible for executing biomedical research while adhering to good clinical practice (GCP) and all applicable ethical and regulatory requirements. Interact and maintain collaborative relationships with the Georgian scientific community. Must have the ability and proficiency analyze data and use Microsoft Office or similar programs.

Demonstrated experience developing and managing research projects required with emphasis on pathogen identification and characterization.

Documented experience performing bacterial or viral culture and/or antimicrobial susceptibility techniques required.

Competitive candidates will demonstrate experience with developing and maintaining funding proposals, standard operating procedures (SOPs), and other knowledge products (e.g., reports, abstracts, presentations).

Microbiology- Principle Investigator (Bacteriologist/ Virologist)

Demonstrated English language proficiency in Level B2 English required, Level C1 preferred. Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation

REQUIREMENT PROFESSIONAL EDUCATION

Responsible for protocol development, submission, management and execution of microbiology research studies. Responsible for assessing, selecting, and implementing standards of new technology in the areas of bacteriology, virology, immunology, and/or molecular diagnostics. Interaction as a member of a team of scientists, clinicians, and technicians responsible for resourcing, executing, analyzing data, and publishing the research. Responsible for developing infectious disease surveillance and research program aims and goals. Responsible for developing and updating infectious disease surveillance and research program protocols, research support documents, research relevant standard operating procedures, and support and initiative for laboratory grant writing efforts. Responsible for developing and implementing training programs. Responsible for executing biomedical research while adhering to good clinical practice (GCP) and all applicable ethical and regulatory requirements. Interact and maintain collaborative relationships with the Georgian scientific community. Must have the ability and proficiency to use and manipulate data and information in MS Outlook, Word, Excel, Power Point or similar programs.

Ph.D. in microbiology, molecular biology, virology, entomology or equivalent from a college or university accredited by the US or their national authority required; 1 year documented experience performing molecular laboratory techniques required. Documented experience in bacteriology or virology required. Documented experience performing bacterial or viral culture and/or antimicrobial susceptibility techniques preferred (Microbiology and Virology PI’s only).

Competitive candidates will have demonstrated with multi-sample platforms such as the ABI 7500 molecular.

Laboratory Technician Level 2

Serves as research technician responsible for conducting research in accordance with established Standard Operating Procedures (SOPs) performing laboratory procedures, testing, and research protocols in fields such as, but not limited to, biochemistry, immunology, microbiology, virology, bacteriology, molecular biology, and toxicology. Must have the ability and proficiency to use and manipulate data and information in MS Outlook, Word, Excel, Power Point or similar programs.

Demonstrated English Language proficiency Level B1 English required, Level B2 preferred. Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation (e.g., Georgian, Bulgaria, Poland, Latvia, etc.) required

Bachelor of Science degree in science in microbiology or related science from a college or university accredited by the US or their national authority with experience in either scientific research or clinical laboratories.

REQUIREMENT PROFESSIONAL EDUCATION

A Bachelor’s degree in entomology, zoology or a life sciences/biology from a college or university accredited by the US or their national authority and prior experience in a research laboratory.

Demonstrable experience (via publications or job history) with microscopic examination of specimens, preparation of laboratory reagents, sterile techniques, and basic tissue culture techniques. Experience with insect rearing, handling live insects, insect collection and identification and BSL-2 containment preferred.

Ability to work in laboratory and field environments. Experience with basic molecular methods (DNA/RNA extraction, PCR). Knowledge of arthropod sample preparation is preferred, but not required

Entomology Laboratory Technician Level 1

Demonstrated knowledge maintaining field-caught and laboratory-reared colonies of arthropods for support to various research programs. Conducts field collections of arthropods for the initiation of new colonies or to support surveillance programs. Acquires and maintains the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop; follows the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources; and ensures that the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance. May require working evenings and weekends. May require overnight travel. Demonstrated experience working independently following a brief period of specific technical training. Demonstrated experience working with mosquitoes and other vectors, and ability to use traditional taxonomic keys to identify vector species. Must have the ability and proficiency to use and manipulate museum curation practices, specifically specimen processing, database management, and collections organization.

Demonstrated proficiency in Level B1 English required, Level B2 preferred.

Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation (e.g., Georgian, Bulgaria, Poland, Latvia, etc.) required.

REQUIREMENT PROFESSIONAL EDUCATION

A Bachelor’s degree in entomology, zoology or a life sciences/biology from a college or university accredited by the US or their national authority and demonstrable experience (via publications or job history) in medical entomology, biology, or biochemistry or related field preferred.

Including microscopic examination of specimens, preparation of laboratory reagents, sterile techniques, and basic tissue culture techniques. Experience with insect rearing, handling live insects, insect collection and identification and BSL-2 containment preferred.

Ability to work in laboratory and field environments. Experience with basic molecular methods (DNA/RNA extraction, real-time polymerase chain reaction (RT-PCR) methods/equipment.

Knowledge of arthropod sample preparation and developing and conducting experiments involving high complexity assays is preferred.

Medical Entomologist Research Associate Level 1

Demonstrated knowledge maintaining field-caught and laboratory-reared colonies of arthropods for support to various research programs. Conducts field collections of arthropods for the initiation of new colonies or to support surveillance programs. Acquires and maintains the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop; follows the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources; and ensures that the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance. May require working evenings and weekends. May require overnight travel. Demonstrated experience working independently following a brief period of specific technical training. Demonstrated experience working with mosquitoes, ticks, sand flies and other vectors, and familiarity with taxonomic and molecular systematics techniques to include an understanding of disease vector morphology. Must have the ability and proficiency to develop, validate, and use traditional taxonomic keys to identify vector species; and manipulate museum curation practices, specifically specimen processing, database management, and collections organization. Acquires and maintains the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop; follows the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources; and ensures that the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed. Interaction as a member of a team of scientists, clinicians, and technicians responsible for resourcing, executing, analyzing data, and publishing research. Interact as a member of a collaborative team in the Georgian scientific community. Demonstrated knowledge conducting research monitoring performance of all field staff to ensure that all log books and records are up to date and comply with all appropriate protocols, SOPs, and regulations. Demonstrated experience working on arthropod surveillance research programs.

Demonstrated proficiency in Level B1 English required, Level B2 preferred.

Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation (e.g., Georgian, Bulgaria, Poland, Latvia, etc.) required.

REQUIREMENT PROFESSIONAL EDUCATION

A Bachelor’s degree in entomology, zoology or a life sciences/biology from a college or university accredited by the US or their national authority and demonstrable experience (via publications or job history) in medical entomology, biology, or biochemistry or related field preferred.

Demonstrable experience (via publications or job history) in microscopic examination of specimens, preparation of laboratory reagents, sterile techniques, and basic tissue culture techniques. Experience with insect rearing, handling live insects, insect collection and identification and BSL-2 containment preferred.

Ability to work in laboratory and field environments. Experience with molecular methods (DNA/RNA extraction techniques, RT-PCR, qPCR, sequencing, Loop-mediated isothermal amplification (LAMP), immunological assays (such as ELISA, Western Blot, etc.) and barcoding arthropods.). Knowledge of arthropod sample preparation and developing and conducting experiments involving high complexity assays is preferred. Knowledge of developing primers and/or probes for molecular assays.

Medical Entomologist Associate Investigator Level

Demonstrated knowledge maintaining field-caught and laboratory-reared colonies of arthropods for support to various research programs. Conducts field collections of arthropods for the initiation of new colonies or to support surveillance programs. Acquires and maintains the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop; follows the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources; and ensures that the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance. May require working evenings and weekends. May require overnight travel. Demonstrated experience working independently following a brief period of specific technical training. Demonstrated experience working with mosquitoes, ticks, sand flies and other vectors, and familiarity with taxonomic and molecular systematics techniques to include an understanding of disease vector morphology. Must have the ability and proficiency to develop, validate, and use traditional taxonomic keys to identify vector species; and manipulate museum curation practices, specifically specimen processing, database management, and collections organization. Acquires and maintains the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop; follows the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources; and ensures that the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed. Interaction as a member of a team of scientists, clinicians, and technicians responsible for resourcing, executing, analyzing data, and publishing research. Interact as a member of a collaborative team in the Georgian scientific community. Demonstrated knowledge conducting research monitoring performance of all field staff to ensure that all log books and records are up to date and comply with all appropriate protocols, SOPs, and regulations. Assist unit and collaborating Principle Investigators (PIs) and Research Coordinators in protocol development, submission, and execution of research studies. Demonstrate knowledge of grant proposal writing for entomology, diagnostic or molecular biology applications.

Demonstrated experience working on arthropod surveillance research programs. Demonstrated knowledge of ability to develop, validate, and implement molecular assays using DNA sequence techniques across multiple platforms, along with standard operating procedures suitable for distribution among multiple testing entities. Provide vector identification support services for DoD costumers and research collaborators upon request. Supervise entomological research contract personnel. Will be required to assist in developing, implementing, and executing training programs for new entomological research personnel.

Demonstrated English Language proficiency Level B1 English required, Level B2 preferred. Demonstrated proficiency to write and review manuscripts published in international journals, take oral/written instructions, keep records, and discuss procedures in English. Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation

REQUIREMENT PROFESSIONAL EDUCATION

Serves as a recognized authority and adviser in the field of human subjects protection and regulatory compliance. Identifies, interprets and supports compliance with regulations, policies, directives, guidelines, and Institutional Review Board (IRB) determinations necessary to support USAMRD-G’s research and surveillance activities. Facilitates protocol compliance with human subjects research guidelines including but not limited to Georgian Law, 32 CFR 219 (“the Common Rule”), 21 CRF 50 & 56 (FDA), DoD Directive 3216.02, AR 70-25, ICH E6 “Good Clinical Practice”). Coordinates USAMRD-G regulatory business between required IRBs and oversight bodies.

Minimum Education/Training Requirements: Bachelor’s Degree or equivalent degree in a scientific discipline from a college or university by the US on their national authority. Masters preferred.

Facilitates the initiation or modification of research documentation for submission to the WRAIR Human Subjects Research Review Board and other regulatory bodies as necessary. Ensures timely proposal review, editing, and submissions in compliance with all applicable human subjects’ protection laws, regulations, policies, procedures, and guidelines.

Minimum Experience: Experience working for an IRB office or as a Clinical Research Coordinator charged with management of protocol portfolios. Familiarity with Georgian IRB guidelines and practices, preferred. Previous U.S. DoD experience a plus. Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred.

Possesses expert knowledge of current regulations and guidelines related to the protection of human subjects in research, and applies knowledge of these regulations and general ethical principles during the review of assigned projects. Provides comprehensive, timely, professional quality written reviews of research protocols that delineate deficiencies and areas of non-compliance. Formulates and recommends unique solutions to complex problems that would help bring protocols into human subjects protection regulatory compliance. Fosters regulatory compliance and human subject’s protection through education and training of key personnel, collaborators and partners and local IRB’s. Develops, coordinates and conducts innovative education and training programs designed to foster human subject’s protection regulatory compliance targeted at personnel in key leadership and/or research roles. Assist in the creation of Federal Wide Assurances (FWA’s) and IRB processes in direct support of USAMRD-G mission accomplishment.

Initiates and assists with requirement identification and preparation of business agreements and contracts supporting USAMRD-G programming. Works closely with collaborators and in-house scientists to develop Cooperative Research and Development Agreements (CRADAs), from implementation, drafting, negotiation, through to execution. Manages business agreement process, including coordination on budgets and incoming funds associated with CRADAs, and communicating with all parties. Requires comprehensive knowledge and understanding of Federal and DoD regulations involving contracts and business agreements. The individual should be able to work independently with minimal supervision.

Human Subjects Protection Advisor and Business Agreement Specialist

Demonstrated English Language proficiency Level B2 English required, Native speaker or demonstrated language proficiency as Level B2 in language of primary country of operation (e.g., Georgian, Bulgaria, Poland, Latvia, etc) required.