A01_Attachment_PWS-P15_Suggested_Personnel_in_Addition_to_Key_Personnel_Final_20180109_SP.docx

ATTACHMENT PWS-P15

SUGGESTED PERSONNEL IN ADDITION TO KEY PERSONNEL

5.21 Contract Employee Suggested Personnel Support. (key personnel listed separately):

5.21.1 Medical Technologist Level II/III (Molecular) CLIN 0001 CLINICAL

5.21.1.1 Duties: Clinical laboratory service delivery (clinical diagnostic testing, clinical and therapeutic monitoring in a CAP, CLIA, CLIP, FDA regulated environment); Molecular Section: use and maintenance of maual, automated, and semi-automated methods with emphasis on performance of Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR), automated real-time PCR, transcription medicated amplification (TMA), nucleic acid testing for quantitative viral load determinations for HIV, STIs and TTIs; qualitative testing for HIV, STIs, clinical monitoring and genotype resistance assays for therapeutic drug monitoring of HIV and molecular testing in support of clinical research.

5.21.1.2 Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent certification is required.

5.21.1.3 Work Environment: BSL Level 2 Laboratory.

5.21.1.4 Work location: National Capital Area

5.21.2 Medical Technologist (Serology; Molecular) Level I/II CLIN 0001 CLINICAL

5.21.2.1 Duties: Clinical laboratory service delivery (clinical diagnostic testing, clinical and therapeutic monitoring in a CAP, CLIA, CLIP, FDA regulated environment); Serology Section: use and maintenance of automated, semi-automated instrumentation and manual methods with an emphasis in serological techniques to include: EIA, Western blot for detection of, but not limited to, HIV-1/HIV-2, HTLV-I/II, HBV, HCV, HSV, syphilis, or other blood borne infection; Molecular Section: nucleic acid detection, nucleic acid quantification, and/or resistance genotyping (sequencing) for, but not limited to, HIV-1/HIV-2, HTLV-I/II, HBV, HCV, HSV, GC, Chlamydia, trichomoniasis, mycoplasma genitalium, or other blood borne pathogens.

5.21.2.2 Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent certification is required.

5.21.2.3 Work Environment: BSL Level 2 Laboratory.

5.21.2.4 Work location: National Capital Area

5.21.3 Clinical Specimen Processor Level I/II CLIN 0001 CLINICAL

5.21.3.1 Duties: support conduct of all pre-test, test, and post-test regulated requirements for processing human and/or animal biological specimens for detection of HIV, STIs, BBI, TTIs, or other prevalent and emerging infectious pathogens of US Military and National interest. Specifically, receipt, processing, and data entry into electronic databases, e.g., LIS, LabWare, FreezerWorks (if applicable), FileMaker Pro, labeling, decapping, and route to appropriate laboratory section for prescribed testing (clinical laboratory service delivery or clinical research), and support conduct of post-test residual sample aliquot, crating, archival storage, and trans-shipment to the DoD Serum Repository or other approved external entity.

5.21.3.2 Work environment: BSL Level 2 Laboratory

5.21.3.3 Work location: National Capital Area

5.21.4 Microbiology Diagnostic Technician - Level II CLIN 0001 CLINICAL

5.21.4.1 Duties: Clinical diagnostic testing; application of HIPAA, CAP, CLIP, and GCLP requirements/standards; histology for identification of parasites in human and animal tissues; parasitic culture; nucleic acid extraction; real time PCR, Leishmania vector diagnostic assays; cellulose acetate electrophoresis, parasite speciation, and xenodiagnoses of Leishmania species.

5.21.4.2 Required Licenses, Certification or Registration: Certificate for animal care and use by American Association for Laboratory Animal Science or equivalent (Level II position) required.

5.21.4.3 Work environment: BSL 2 laboratory and animal BSL 2 Laboratory.

5.21.4.4 Work location: National Capital Area

5.21.5 Microbiology Diagnostic Technician - Level I CLIN 0001 CLINICAL

5.21.5.1 Duties: Clinical diagnostic testing; application of HIPAA, CAP, CLIP, and GCLP requirements/standards; histology for identification of parasites in human and animal tissues; parasitic culture; nucleic acid extraction; real time PCR, Leishmania vector diagnostic assays; cellulose acetate electrophoresis, parasite speciation, and xenodiagnoses of Leishmania species.

5.21.5.2 Required Licenses, Certification or Registration: No licenses, or certification required.

5.21.5.3 Work environment: BSL 2 laboratory and animal BSL 2 Laboratory.

5.21.5.4 Work location: National Capital Area.

5.21.6 Project Manager CLIN 0002 Laboratory Operations

5.21.6.1 Duties: Scientific project management; knowledge of regulatory agency requirements with emphasis on GCLP, CAP, CLIP; knowledge of tracking performance measures, reporting cycles, milestones, project reviews; experience in managing third party contributions and dependences and interfaces between projects; preparation of SOPS, Gantt charts, and Excel Worksheets.

5.21.6.2 Required Licenses, Certification or Registration: Certification as Medical Technologist or equivalent is required.

5.21.6.3 Work environment: may involve work in and around BSL Level 2 Laboratories.

5.21.6.4 Work location: National Capital Area.

5.21.7 Project Coordinator/Trainer CLIN 0002 Laboratory Operations

5.21.7.1 Duties: Conduct, oversight, implementation, and identification of areas of operational improvement for training programs supporting regulated activities, e.g., CAP, CLIA

5.21.7.2 Required Licenses, Certification or Registration: Certification as Medical Technologist or Clinical Research Associate, or equivalent is required.

5.21.7.3 Work environment: may involve work in and around BSL Level 2 Laboratories

5.21.7.4 Work location: National Capital Area.

5.21.8 Quality Assurance Specialist Level I /II CLIN 0002 Laboratory Operations

5.21.8.1 Duties: QA implementation in a non-waived, high complexity laboratory environment; maintenance of CAP/CLIP and FDA regulatory compliance for laboratory quality operations to include pre-test (analytical), test (analytical) , and post-test (post-analytical) performance indicators, maintenance of QSEs practices; monitoring process controls, QC data, trends; maintenance and management of records.

5.21.8.2 Required Licenses, Certification or Registration: No license, certification required.

5.21.8.3 Work environment: involves work in and around BSL Level 2 Laboratories; regulated office environment.

5.21.8.4 Work location: National Capital Area.

5.21.9 Quality Assurance Specialist (Document Control Officer) CLIN 0002 Laboratory Operations

5.21.9.1 Duties: QA implementation in a non-waived, high complexity laboratory environment; maintenance of CAP/CLIP and FDA regulatory compliance for laboratory quality operations to include pre-test (analytical), test (analytical) , and post-test (post-analytical) performance indicators, maintenance of QSEs practices; monitoring process controls, QC data, trends; maintenance and management of records.

5.21.9.2 Required Licenses, Certification or Registration; No license or certification is required.

5.21.9.3 Work environment: involves work in and around BSL Level 2 Laboratories; regulated office environment.

5.21.9.4 Work location: National Capital Area.

5.21.10 Administrative Assistant – Senior (Office Manager/Client Services) CLIN 0002 Laboratory Operations

5.21.10.1 Duties: Performance of demographic data checks to ensure correct data entry, generation of accurate final reports for submitting entities upon completion of clinical testing and/or as requested by site point of contacts, knowledge of regulatory agency and accrediting body (CAP, CLIP, FDA) archival storage requirements for electronic and hard copy reports. Ability to confidently engage staff at all levels to define needs and expectations, engage collaborators as required. General office duties to ensure productive, efficient work flows; management of multiple competing time sensitive priorities; maintenance of office equipment, to include but not limited to copiers, faxes, and computers.

5.21.10.2 Required Licenses, Certification or Registration; Certification as Clinical Research Professional, Clinical Research Associate, or equivalent.

5.21.10.3 Work Environment: some exposure to BSL Level 2 Laboratory; regulated office environment.

5.21.10.4 Work Location: National Capital Area.

5.21.11 Administrative Assistant - (Client Service Representative) CLIN 0002 Laboratory Operations

5.21.11.1 Duties: Basic understanding of QC Mean, Standard Deviation and trends; medical terminology, and medical office and/or medical laboratory operations. Maintain confidentiality, protecting private health information, supporting client requests. Biology, or other related health or scientific background helpful.

5.21.11.2 Required Licenses, Certification or Registration; No license or certifications required.

5.21.11.3 Work Environment: some exposure to BSL Level 2 Laboratory; regulated office environment.

5.21.11.4 Work Location: National Capital Area.

5.21.12 LIS Programmer and Software Analyst Level I/II CLIN 0002 Laboratory Operations

5.21.12.1 Duties: Evaluation of LIS systems for support of laboratory operations, recommendation of priorities for design and implementation efforts; Planning, design, development, and deployment of new LIMS applications and enhancements to exiting LIS and software systems.

5.21.12.2 Required Licenses, Certifications, or Registration: No license or certification required.

5.21.12.3 Work environment: some exposure to BSL Level 2 Laboratories; regulated office environment.

5.21.12.4 Work location: National Capital Area.

5.21.13 Research Medical Technologist Level I (Lab Scientist) CLIN 0003 Clinical Research

5.21.13.1 Duties: Performance of serological, immunological, molecular testing procedures for STIs, BBIs, TTIs; clinical specimen testing in accordance with SOPs, GCLP, and CAP/CLIP/FDA regulatory agency requirements; preparation of SOPS and Excel Worksheets.

5.21.13.2 Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent preferred. Certified shipper (49CFR and IATA) mandatory.

5.21.13.3 Work environment: BSL Level 2 Laboratory.

5.21.13.4 Work location: National Capital Area; may involve international travel.

5.21.14 Research Assistant Level II CLIN 0003 Clinical Research

5.21.14.1 Duties: Public health research/clinical diagnostic laboratory; knowledge of molecular biology and cellular techniques: RNA and DNA extractions, amplification of RNA and DNA (RT- PCR and PCR), electrophoresis, Digital Droplet PCR, DNA sequencing, sequence analysis, sterile technique, and tissue culture; us of Macintosh and/or PC related software (i.e. Excel and Microsoft Word); knowledge in regulatory requirements for clinical testing under CLIA, CLIP, GCLP, FDA and CAP.

5.21.14.2 Required Licenses, Certification or Registration: No license or certification required.

5.21.14.3 Work Environment: BSL Level 2 Laboratory.

5.21.14.4 Work location: National Capital Area.

5.21.15 Research Assistant Level III CLIN 0003 Clinical Research

5.21.15.1 Duties: Knowledge of molecular biology and cellular techniques: RNA and DNA extractions, amplification of RNA and DNA (digital droplet PCR, RT-PCR and PCR), electrophoresis, DNA sequencing, sterile technique, and tissue culture. Experience in the use of Macintosh and/or PC related software (i.e. Excel and Microsoft Word performance of laboratory testing procedures. Experience in the regulatory requirements for clinical testing under GCLP, CLIP, and College of American Pathogen (CAP).

5.21.15.2 Required Licenses, Certification or Registration: No license or certification required.

5.21.15.3 Work Environment: BSL Level 2 Laboratory

5.21.15.4 Work Location: National Capital Area

5.21.16 Staff Scientist Level 1 - CLIN 0003 Clinical Research

5.21.16.1 Duties: Application of analytical theories and practices, scientific principles, and concepts to advance HIV, BBI, STI, and TTI research; Application of relevant regulatory, laboratory, and ethical requirements for conduct of regulated clinical, translational, applied research; supervision of technical personnel; writing specialized scientific and technical reports; designing, developing, preparing research protocols, peer reviewed manuscripts, regulatory documents; preparation of presentations at national and international scientific forums.

5.21.16.2 Required Licenses, Certification or Registration: No license or certification required.

5.21.16.3 Work Environment: BSL Level 2 Laboratory

5.21.16.4 Work location: National Capital Area.

5.21.17 Associate Laboratory Director - CLIN 0004 Surge Clinical (HDRL/LDL)

5.21.17.1 Duties: Oversight of a non-waived, high complexity clinical testing laboratory; application of accrediting and regulatory agency requirements for non-waived, high complexity clinical testing, Federal, and state laws; application of laboratory information management and automation systems; ability to recommend corrective action and policy changes to correct deficiencies and improve laboratory programs/operations. Techniques include: enzyme immunoassay (EIA), Western blot for detection of, but not limited to, HIV-1/HIV-2, HTLV-I/II, HBV, HCV, HSV, syphilis, or other blood borne infection; nucleic acid detection, nucleic acid quantification, and/or sequencing for, but not limited to, HIV-1/HIV-2, HTLV-I/II, HBV, HCV, HSV, GC, Chlamydia, trichomoniasis, mycoplasma genitalium, or other blood borne pathogens.

5.21.17.2 Required Licenses, Certification or Registration: No license of certification required.

5.21.17.3 Work environment: BSL Level 2 Laboratory; regulated office environment.

5.21.17.4 Work location: National Capital Area.

5.21.18 Medical Technologist III - Assistant Laboratory Manager – CLIN 0004 Surge Clinical (HDRL/LDL)

5.21.18.1 Duties: Oversight of a non-waived, high complexity clinical laboratory as a Technical Supervisor; Application of accrediting and regulatory agency requirements for non-waived, high complexity clinical testing, Federal, and state laws; knowledge of laboratory information management and automation systems; ability to recommend corrective action and policy changes to correct deficiencies and improve laboratory programs/operations.

5.21.18.2 Required Licenses, Certifications or Registration: Certification as Medical Technologist, ASCP or equivalent certification is required.

5.21.18.3 Work environment. BSL Level 2 Laboratory.

5.21.18.4 Work location. National Capital Area

5.21.19 Assistant Quality Assurance Manager - CLIN 0005 Surge Laboratory Operations

5.21.19.1 Duties: Performance in Non-waived, high complexity clinical laboratory environment. Maintenance of CAP/CLIP and FDA regulatory compliance for all aspects of laboratory quality operations to include all pre-test (analytical), test (analytical), and post-test (post-analytical) performance indicators and process controls; maintenance and advancement of the application QSEs to laboratory operations; Management of Quality Manage and Quality Improvement Programs.

5.21.19.2 Required Licenses, Certification or Registration: Certification as Medical Technologist, ASCP or equivalent certification is required.

5.21.19.3 Work environment: in and around. BSL2 Laboratory; regulated office environment.

5.21.19.4 Work location: National Capital Area.

5.21.20 Software Analyst/Data Manager CLIN 0005 Surge Laboratory Operations

5.21.20.1 Duties: Laboratory operations/support services conducted with in regulated environments; support of LIS Programmer and administrative functions of Laboratory Information System; LIS administrative functions; software applications support for laboratory operations to include, but not limited to specimen management systems, document control, environmental monitoring control, and data analysis at a computer terminal; experience in management and manipulation of data generated from clinical and clinical research; experience in handling large data sets, awareness of data quality and integrity issues, and familiarity with programming in a clinical and clinical research environments. Biology, or other related health or scientific background helpful.

5.21.18 5.21.19

5.21.20.2 Required Licenses, Certification or Registration: No license or certification is required.

5.21.20.3 Work environment: in and around. BSL2 Laboratory; regulated office environment.

5.21.20.4 Work location: National Capital Area.

5.21.21 Project Coordinator I/II CLIN 0005 Surge Laboratory Operations

5.21.21.1 Duties: Managing a fast- paced research environment coordinating multiple priorities with different timelines/milestones; project management skills; Interaction with international investigators/scientist of diverse cultural backgrounds; data review and/or analysis for presentations at scientific forms.

5.21.21.2 Required Licenses, Certification or Registration: No license required.

5.21.21.3 Work environment. May involve work in and around BSL Level 2 Laboratories.

5.21.21.4 Work location: National Capital Area.

5.21.22 Post Doctor Fellow Level 1/II CLIN 0006 Surge Clinical Research

5.21.22.1 Duties: Performance of scientific studies in the field of Public health research/clinical diagnostic laboratory; knowledge of molecular biology and cellular techniques: RNA and DNA extractions, amplification of RNA and DNA (RT- PCR and PCR), electrophoresis, Digital Droplet PCR, DNA sequencing, sequence analysis, sterile technique, and tissue culture, serological techniques; advanced biology or other related scientific field helpful.

5.21.22.2 Required licenses, certification, or registration: No license or certification required.

5.21.22.3 Work Environment: BSL Level 2 Laboratory.

5.21.22.4 Work location: National Capital Area

5.21.23 Administrative Assistant – Junior CLIN 0009

5.21.23.1 Duties: Use of Microsoft Office Suite (Word, Excel, Powerpoint), databases (File Maker Pro) in support of senior DLM leadership; communication skills; ability to handle multiple priorities, ability to maintain confidentiality, protect private health information, personal identifying information. Ability to work in a highly collaborative, regulated environment.

5.21.23.2 Required licenses, certification, or registration: No license or certification required.

5.21.23.3 Work environment: regulated office environment.

5.21.23.4 Work location: National Capital Area

5.21.24 Administrative Assistant – Senior (Executive Assistant) CLIN 0009; CLIN 0010

5.21.24.1 Duties: Organization skills, use of Microsoft Office Suite, data bases (File Maker Pro), and communication skills; ability to handle multiple priorities, ability to maintain confidentiality in support of senior DLDM leadership, protect private health information, and/or personal identifying identification. Ability to confidently engage staff at all levels to define needs and expectations, engage collaborators as required. Ability to work independently in a highly collaborative environment.

5.21.24.2 Required License, Certification, or Registration: No license, or certification required.

5.21.24.3 Work Environment: regulated office environment.

5.21.24.4 Work Location: National Capital Area.

5.21.25 Public Health Nurse CLIN 0008 DETA Surge

5.21.25.1 Duties: licensed clinical nursing; Active, unrestricted license in the state of the Medical Treatment Facility duty location (e.g. Womack Army Medical Center, North Carolina).

5.21.25.2 Familiarity with VA/DoD Healthcare and health information systems required, Prior U.S. military service desired. Patient/participant tracking and education/preventive intervention/screening service delivery and data acquisition.

5.21.25.3 Work environment: Primarily office setting with occasional clinical setting.

5.21.26 Project Coordinator CLIN 0007

5.21.26.1 Duties: interact with international investigators/scientists of diverse cultural backgrounds; data view and/or analysis for presentations at scientific forms.

5.21.26.2 Required Licenses, Certification or Registration: No license required.

5.21.26.3 Work environment: regulated office environment.

5.21.26.4 Work location: National Capital Area with occasional U.S. and international travel.

5.21.27 Public Health Research Assistant –Level II CLIN 0008 DETA Surge

5.21.27.1 Duties: Conducting and preparing standard epidemiological study and public health investigation design; Knowledge of statistical and mathematical software such as SAS, STATA, or equivalent; compliance with CV, CITI and HIPAA certifications. Develop a working knowledge of military culture.

5.21.27.2 Required Licenses, Certification or Registration: No license required

5.21.27.3 Work Environment: Office, laboratory, and domestic and possible international field site environment. Approximately 10% international and domestic travel; potential for episodic extended domestic travel up to approximately 25% of the time.

5.21.27.4 Work location: National Capital Area.

5.21.28 Outreach Worker/Coordinator CLIN 0007

5.21.28.1 Duties: Developing, coordinating and managing individual and group communications and program facilitation plans in traditional/venue-based outreach and electronic/social media outreach; work with Service members and military beneficiary populations. Prior military service preferred and is acceptable in lieu of undergraduate education.

5.21.28.2 Required Licenses, Certification or Registration: No license required.

5.21.28.3 Work environment: office environment, some field work.

5.21.28.4 Work location: National Capital Area or San Antonio, Texas. Occasional domestic travel required.

5.21.29 Medical Economist CLIN 0008 DETA Surge

5.21.29.1 Duties: developing medical economic models that inform clinical and or public health policy and practice. Proficiency with developing models from a wide variety of perspectives.

5.21.29.2 Required license, Certification, or Registration: No license, certification required.

5.21.29.3 Work location: National Capital Area.

5.21.30 Public Health Research Assistant Level I CLIN 0007

5.21.30.1 Duties: Public health/behavioral change research with field work experience involving direct contact with military service member and beneficiary research subjects to include participant recruitment, delivery of preventive interventions, and clinical/behavioral follow up. Data extraction from DoD clinical data systems. Communication using interpersonal, oral, and written communication methods.

5.21.30.2 Required Licenses, Certification, or Registration: No license, certification required.

5.21.30.3 Work environment: Office environment.

5.21.30.4 Work location: Joint Base Lewis McChord, Washington and Fort Wainwright, Alaska.

5.21.31 Data Manager/Statistical Analyst System (SAS) Programmer CLIN 0008 DETA Surge

5.21.31.1 Duties: Data extraction and statistical computation using SAS programming language, especially basic SAS procedures (CIMPORT, GRAPH, COMPARE, CONTENTS, CPORT, EXPORT, FORMAT, FREQ, IMPORT, MEANS or UNIVARIATE, PRINT, REPORT, SORT, SQL) and the DATA step and the performance of programming tasks in a SAS/Oracle environment.

5.21.31.2 Required Licenses, Certification, or Registration: No license, certification required.

5.21.31.3 Work environment: Office

5.21.31.4 Work location: National Capital Area.

5.21.32 Project Manager CLIN 0008 DETA Surge

5.21.32.1 Duties: Managing multiple projects in a fast-paced research environment coordinating multiple priorities with different timelines/milestones; interacting with international investigators/scientist of diverse cultural backgrounds; data review and/or analysis for presentations at national and international scientific forums.

5.21.32.2 Required Licenses, Certification or Registration: No license, certification required.

5.21.32.3 Work environment: Office

5.21.32.4 Work location: National Capital Area.

5.21.33 Public Health Research Physician CLIN 0007

5.21.33.1 Duties: Licensed Medical Doctor (MD), Doctor of Osteopathic Medicine (DO) with post graduate training in Public Health, Infectious Diseases, or a related field, experience conducting all phases of public health research, experience managing multidisciplinary public health research teams, knowledge of relevant regulatory, laboratory, and ethical policies, experience executing military relevant HIV/HIV-related infections military research.

5.21.33.2 Required Licenses, Certification or Registration: Requires active, unrestricted license to practice medicine in any state in the United States.

5.21.33.3 Work location: National Capital Area with occasional domestic and international travel

5.21.34 Health Psychologist / Behavioral Researcher CLIN 0008 DETA Surge

5.21.34.1 Duties: Experience conducting all phases of behavioral intervention studies, experience managing investigative teams, knowledge of relevant regulatory, laboratory, and ethical policies, experience executing military relevant behavioral research aimed at modifying HIV/HIV-related infections and associated risk behaviors.

5.21.34.2 Required Licenses, Certification or Registration: No license required.

5.21.34.3 Work environment: Office

5.21.34.4 Work location: Joint Base Lewis McChord, Washington and Fort Wainwright, Alaska.

5.21.35 Epidemiologist CLIN 0008 DETA Surge

5.21.35.1 Duties: scientific experience conducting all phases of complex epidemiologic, public health, laboratory, behavioral, and interventional research studies, and knowledge commensurate with conducting standard epidemiological study and public health investigation design, knowledge of relevant regulatory, laboratory, and ethical policies, experience executing military relevant behavioral research aimed at modifying HIV/HIV-related infections and associated risk behaviors.

5.21.35.2 Required Licenses, Certification or Registration: No license, certification required.

5.21.35.3 Work environment: Office

5.21.35.4 Work location: National Capital Area.