A01_Attachment_PWS-P15_Suggested_Personnel_in_Addition_to_Key_Personnel_Final.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 II/III (Molecular) CLIN 0001 CLINICAL

5.21.1.1 Duties: Performance of manual Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR), automated real-time PCR, nucleic acid testing for viral load determinations for HIV, STI, and TTIs; clinical monitoring and genotype resistance assays for therapeutic drug monitoring of HIV;

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

5.21.2 Medical Technologist (Serology; Molecular) 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 certified is required.

5.21.3 Clinical Specimen Processor I/II CLIN 0001 CLINICAL

5.21.4 Microbiology Diagnostic Technician - Level 1 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 Work environment: BSL 2 laboratory and animal BSL 2 laboratory.

5.21.5 Project Manager CLIN 0002 Laboratory Operations

5.21.5.1 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.

5.21.5.2 Work environment: BSL 2 laboratory.

5.21.6 Project Coordinator/Trainer CLIN 0002 Laboratory Operations

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

5.21.7 Quality Assurance Specialist I /II CLIN 0002 Laboratory Operations

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

5.21.8.1 Required Licenses, Certification or Registration

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

5.21.9.1 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. 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.

5.21.9.2 Work Environment: some exposure to BSL2 Laboratory.

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

5.21.10.1 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.

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

5.21.10.1 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 systems.

5.21.11 Research Medical Technologist I (Lab Scientist) CLIN 0003 Clinical Research

5.21.11.1 Duties: Performance of serological, immunological, molecular testing procedures; clinical specimen testing in accordance with SOPs, GCLP, and CAP/CLIA/FDA regulatory agency requirements; preparation of SOPS and Excel Worksheets.

5.21.11.2 Required Licenses, Certification or Registration: Certified shipper (49CFR and IATA) mandatory; ASCP certified preferred.

5.21.11.3 Work environment: BSL 2 laboratory.

5.21.12 Research Assistant Level II CLIN 0003 Clinical Research

5.21.12.1 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.

5.21.12.2 Work Environment: BSL 2 laboratory.

5.21.13 Staff Scientist Level 1 - CLIN 0003 Clinical Research

5.12.13.1 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.

5.12.13.2 Work Environment: BSL 2 laboratory

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

5.21.14.1 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.

5.21.14.2 Work environment. BSL2 Laboratory.

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

5.21.17.1 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.

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

5.21.18 Assistant Quality Assurance Manager - CLIN 0005 Surge Laboratory Operations

5.21.18.1 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.

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

5.21.19 Software Analyst/Data Manager CLIN 0005 Surge Laboratory Operations

5.21.19.1 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.

5.21.20 Project Coordinator I/II CLIN 0005 Surge Laboratory Operations

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

5.21.21.1 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; Advanced biology or other related scientific field helpful.

5.21.21.2 Work Environment: BSL 2 laboratory.

5.21.22 Administrative Assistant – Junior CLIN 0009

5.21.23 Administrative Assistant – Senior (Executive Assistant) CLIN 0009

5.21.24 Public Health Nurse CLIN 0007

5.21.24.1 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).

5.21.24.2 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.

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

5.21.25 Project Coordinator CLIN 0007

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

5.21.25.2 Potential occasional travel to CONUS and/or OCONUS sites.

5.21.26 Public Health Research Assistant –Level II CLIN 0007

5.21.26.1 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.

5.21.26.2 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%.

5.21.27 Outreach Worker/Coordinator CLIN 0007

5.21.27.1 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 Medical Economist CLIN 0007

5.21.28.1 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 Public Health Research Assistant Level 1 CLIN 0007

5.21.29.1 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 Data Manager/Statistical Analyst System (SAS) Programmer CLIN 0007

5.21.30.1 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 Project Manager CLIN 0008

5.21.31.1 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 Public Health Research Physician CLIN 0007

5.21.32.1 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 Health Psychologist / Behavioral Researcher CLIN 0007

5.21.33.1 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 Epidemiologist CLIN 0007

5.21.34.1 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.