Attachment_A_-_Labor_Categories_and_Descriptions.docx

Attachment A W911QY-17-R-0049 Labor Categories and Descriptions

1. Clinical Monitors: Prepare and send visit confirmation letter to site, review relevant information including, but not limited to, previous visits, review protocols and essential documents, review of Standard Operating Procedures (SOPs). Conduct site visits as dictated by the monitoring plan, focusing on: a. Subject entry criteria, b. Informed consent process verification of data accuracy and protocol/study compliance, c. verify Source Data (100% of subjects/100% of Data) including, d. Entry criteria, e. Informed consent (ICF) process verification (review ICFs on all subjects identified), f. Essential Regulatory Document review and ICF contents, g. Primary efficacy and safety endpoints, h. Serious Adverse Events, i. Clinical Event Endpoints with review and collection of adjudication documents, j. review investigator files, and k. communicate with site Investigator/coordinator any issues that require follow up, action(s) to be taken, and expected timelines for completion for all action items. Complete the monitoring follow up letter sent to Investigator outlining the pertinent points discussed, and the agreed upon action items. Provide documentation of visit by a trip report in an agreed upon format, and subsequent written summaries of follow up communications within 30 business days of visit. Use Close Out Visit guidelines to verify the completeness of the site file and Close out procedures, assist with any final questions regarding the data collected, review final Case Report Forms (CRFs) and verify that all corrections were made, provide information and assistance to the site center regarding study records retention, provide information and assistance with handling potential FDA inspections, and monitor site data quality and query status, and assist with data and query resolution, as the studies will be conducted via Electronic Data Capture and/or paper Case Report Forms. Department: Behavioral Biology

2. Clinical Research Associate I (CRA, Clinical Monitor): Participates in the design, administration and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Requires a BS, RN, or BSN degree or equivalent and minimum of 1 year of experience in the field or in a related area. Knowledge of FDA regulatory requirements is required. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager. Department: Behavioral Biology

3. Clinical Research Associate III (CRA, Clinical Monitor): Participates in the design and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Requires a BS, RN, or BSN degree or equivalent and a minimum of 5 years of experience in the field or in a related area. Knowledge of FDA regulatory requirements is required. Familiar with a variety of the field's concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks. Typically reports to a supervisor or manager. A wide degree of creativity and latitude is expected. Department: Behavioral Biology

4. Sleep Laboratory Research Technician: Assist the Principal Investigators (PIs) with designing research studies and providing scientific input into the research process. Be responsible for the execution of research studies including all aspects of data collection, supporting data management and data analyses, designing surveys, coordinating data collections, collecting survey and interview data, processing data, archiving data, and preparing codebooks. Assist in preparing Command Briefings, technical reports, and manuscripts for publication in professional journals. Design research studies to include reviewing and understanding applicable regulations and guidelines. The contractor shall organize and prioritize all activities associated with designing research studies. Maintain a safe work environment, ensuring that it complies with all safety and occupational health rules and regulations. Be required to attend all safety training sessions relative to carrying out the design of research studies, reporting all infractions of safety procedures to the facility Safety Officer. Department: Behavioral Biology

5. Sleep Laboratory Coordinator: Perform Clinical Research Coordination as directed by the Internal Review Board (IRB), providing protocol coordination, assistance with proposal writing projects, and assistance with progress and technical reports. Organize and prioritize all activities associated with conducting laboratory- and field based human use protocols. The contractors shall review and understand protocols, ensuring applicable regulations and guidelines are followed. The contractors shall coordinate with external and internal monitors. The contractors shall maintain compliance with specific protocol, SOPs, regulations and guidelines. Provide clinical expertise/knowledge to other staff in the department. Monitor volunteer safety, compliance and health status as needed, and follow through with the appropriate physician. Department: Behavioral Biology and NICoE

6. Experimental Human Stress Study Specialist (Key Personnel): Ph.D. in Psychology with research experience in lab-based and/or field settings. At least 4 publications in the peer-reviewed literature demonstrating scientific merit of work and expertise as an experimental psychologist is desirable. Ability to attach psychophysiological equipment (small electrodes, etc.) requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. Works primarily in a sleep laboratory or in the field. Handles biological materials and lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents. Proficiency in most Windows programs (e.g., Word, Excel, PowerPoint); ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology

7. Sleep Laboratory Manager (Key Personnel): Knowledge of/experience with FDA regulations, rules, and policies affecting conduct, record-keeping, and monitoring of human protocols involving investigational new drugs. This position also requires the ability to teach these practices to others (students, enlisted soldiers, etc.) as appropriate, and to monitor study data collection procedures to ensure uniformly high levels of compliance with FDA-required practices throughout all phases of the study: preparation, conduct, analysis, and archiving of clinical data. Oversee technical and logistical aspects of the conduct of human research in the fields of: sleep, sleep deprivation, electroencephalography, psychophysiology, and others—and aids in the statistical analyses, presentation, and publication of resulting data sets – to include assisting in the preparation of any progress and/or final reports to the FDA and/or commercial (e.g., pharmaceutical industry) sponsors of IND research. Knowledge of ICH/GCP and FDA/CFR guidelines for pharmacological agents used in human use research or past related experience showing the ability to master similar skills is a critical requirement. Department: Behavioral Biology and NICoE

8. Clinical Research Coordinator: Organizes research information for clinical projects. Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Requires a Bachelor's degree, preferred Registered nurse licensed in the state of Maryland and a minimum of 3 years work experience in clinical research setting as research coordinator. CCNC certification is REQUIRED. Familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under general supervision. A certain degree of creativity and latitude is required. Typically reports to a supervisor or manager. Department: Behavioral Biology and NICoE

9. Physician Assistant/Nurse Practitioner (Key Personnel): Provides support of research protocols, including Good Clinical Practice and FDA-regulated clinical trials. Records all laboratory procedures and research project data, data analyses and analytical conclusions of analyses. Desires knowledge in the areas of research licensed nursing, regulatory affairs, and clinical safety as related to clinical studies, healthcare management, and technology-based training and education programs. Must be licensed physician assistant or licensed nurse and a minimum of 5 years of experience in a research setting with direct volunteer medical care and oversight, to include but not limited to volunteer medical screening, determination of volunteer medical fitness to participate, administration of test article to volunteers, identification and tracking of volunteer adverse events. Department: Behavioral Biology and NICoE

10. Brain Trauma Research Scientist (Neuroscientist) (Key Personnel): Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a graduate degree in Neuroscience, Neurobiology, Molecular Biology, Psychology or other related scientific field and a minimum of 3 years of post-Doctorate experience in the field or in a related area. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Ability to lead. Ability to operate research equipment requiring manual dexterity. Ability to handle research animals, wear appropriate personal protective equipment, and work in a Biosafety Level (BSL) 1 laboratory. Ability to utilize office automation equipment, including computers, photocopiers, telephones, and telefax machines. Department: BTNN

11. Brain Trauma Research Fellows (Neuroscientists) (Key Personnel): Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a graduate degree in Neuroscience, Neurobiology, Molecular Biology, Psychology or other related scientific field. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Performs a variety of tasks. Ability to lead. Ability to operate research equipment requiring manual dexterity. Ability to handle research animals, wear appropriate personal protective equipment, and work in a Biosafety Level (BSL) 1 laboratory. Ability to utilize office automation equipment, including computers, photocopiers, telephones, and telefax machines. Department: BTNN

12. Research Associate (Technician): Performs research activities and other tasks as necessary in a laboratory environment. Records observations and measurements and reports results. Responsible for cleaning, disinfecting, and maintaining cleanrooms and equipment. Assists with receipt and inspection of raw materials, and ordering and stocking of materials and equipment. Requires a bachelor's degree in Neuroscience, Neurobiology, Molecular Biology, Psychology or other related scientific field and a minimum of 5 years of experience in the field or in a related area. Familiar with standard concepts, practices, and procedures within a particular field. Ability to operate research equipment requiring manual dexterity. Ability to handle research animals, wear appropriate personal protective equipment, and work in a Biosafety Level (BSL) 1 laboratory. Ability to utilize office automation equipment, including computers, photocopiers, telephones, and telefax machines. Department: BTNN

13. Research Technicians II: Performs research activities and other tasks as necessary in a laboratory environment. Records observations and measurements and reports results. Responsible for cleaning, disinfecting, and maintaining cleanrooms and equipment. Assists with receipt and inspection of raw materials, and ordering and stocking of materials and equipment. Requires a Master's degree in Neuroscience, Neurobiology, Molecular Biology, Psychology or other related scientific field and a minimum of 2 years of experience in the field or in a related area. Familiar with a variety of the field's concepts, practices, and procedures. Performs a variety of tasks. Ability to operate research equipment requiring manual dexterity. Ability to handle research animals, wear appropriate personal protective equipment, and work in a Biosafety Level (BSL) 1 laboratory. Ability to utilize office automation equipment, including computers, photocopiers, telephones, and telefax machines. Department: BTNN

14. Research Technician I: Performs research activities and other tasks as necessary in a laboratory environment. Records observations and measurements and reports results. Responsible for cleaning, disinfecting, and maintaining cleanrooms and equipment. Assists with receipt and inspection of raw materials, and ordering and stocking of materials and equipment. Requires a Bachelor's degree in Neuroscience, Neurobiology, Molecular Biology, Psychology or other related scientific field and a minimum of 1 year of experience. Performs a variety of tasks. Ability to operate research equipment requiring manual dexterity. Ability to handle research animals, wear appropriate personal protective equipment, and work in a Biosafety Level (BSL) 1 laboratory. Ability to utilize office automation equipment, including computers, photocopiers, telephones, and telefax machines. Department: BTNN

15. Administrative Assistant: Performs a variety of administrative functions. Schedules appointments, gives information to callers, and takes dictation. Composes memos, transcribes notes, and researches and creates presentations. Generates reports, handles multiple projects, and prepares and monitors invoices and expense reports. May assist with compiling and developing the annual budget. Requires a high school diploma with little experience in the field or in a related area. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Familiar with a variety of the field's concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks Works under immediate supervision. Typically reports to a supervisor or manager. Department: Military Psychiatry Branch

16. Program Coordinator (Key Personnel): Coordinates scheduling, and technical performance of company programs. Responsibilities also include aiding in contractual changes and coordinating preparations of proposals, plans, and specifications of contracts. Ensures adherence to master plans and schedules, develops solutions to program problems, and directs work of incumbents assigned to program from various departments. Ensures projects are completed on time and within budget. Acts as advisor to program team regarding projects, tasks, and operations. Requires a bachelor's degree and a minimum of 5 years of experience in the field or in a related area. Familiar with standard concepts, practices, and procedures within a particular field. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of complex tasks. A certain degree of creativity and latitude is required. Typically reports to a unit/department head. Department: Military Psychiatry Branch

17. Trainer (Key Personnel): Designs and conducts military training programs. Monitors and reports the effectiveness of training during an initial period and for a defined period. May be involved in initial plan design and existing plan enhancements. Requires a bachelor's degree in a related area and a minimum of 10 years of experience Developing and Conducting Military Training or in a related area such as Communications, Program Evaluation, or Consulting. Has knowledge of commonly-used concepts, practices, and procedures within the Training field. Relies on extensive experience and judgement to plan and accomplish goals. Works under immediate supervision. May provide consultation on complex projects and is considered to be the top level contributor/specialist. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Department: Research Transition Office

18. Product Development Manager (Key Personnel): Requires a minimum of 5 years of experience in a product development role, preferably at the level of Product Manager. Strong verbal & written communication skills. Knowledge of competitive intelligence for increased awareness of trends & price points. Requires college Degree (a minimum of 15 cumulative credits in business related courses) or equivalent experience. A minimum of 5 years using a computer and automation systems and a minimum of 2 years of experience using Remark Office Optical Mark Recognition (OMR). Prefer previous experience in managerial, professional or technical work experience and/or training which has provided knowledge of management principles, practices, methods and techniques. Department: Research Transition Office

19. Polysomnographic Technician: Assist in conducting and scoring polysomnographic studies. Requires a Bachelor’s Degree and a minimum of 1 year of relevant experience. Must maintain certification in Basic Life Support (BLS) and registry certification for the profession. Should also possess a minimal proficiency in common productivity software programs including Word, Excel, SigmaPlot and others, and have an understanding of basic descriptive statistics. Department: Behavioral Biology

20. Mental Health Researcher (Key Personnel): Participates in research and development activities to investigate the extent to which differences in chronic and/or acute sleep debt account for individual differences in TBI-related neurocognitive/ vestibular/ physiological/ psychomotor deficits and help establish the potential utility of the objective assessment of sleep (with actigraphy and/or polysomnography) in a patient population. Assist in recruiting, screening, consent, and scheduling. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a doctorate degree in Psychology or other Behavioral Health fields and a minimum of 5 years of experience in the field and a minimum of 5 years working in a Military setting. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May provide consultation on complex projects and is considered to be the top level contributor/specialist. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Department: Military Psychiatry Branch, Research Transition Office

21. Principal Investigator (Key Personnel): Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a doctorate degree in area of specialty and a minimum of 8 years of experience in the field or in a related area. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May provide consultation on complex projects and is considered to be the top level contributor/specialist. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Department: Military Psychiatry Branch, West Detachment – JBLM

22. Research Assistant (Key Personnel): Participates in research and development activities. Utilizes established mathematical and scientific techniques to compile and analyze data. Writes technical reports detailing procedures, outcomes, and observations. Requires a Bachelor's or Master's degree in Behavioral Science and a minimum of 2 years of experience in the field or in a related area. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Must be proficient with or willing to learn Statistical Programming for the Social Sciences (SPSS) programming for data manipulation and statistical analyses as well as Remark Office Software for both the creation of surveys and the scanning of surveys. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager. Department: Military Psychiatry Branch, West Detachment – JBLM

23. Animal Behavior Research Assistant (Key Personnel): Conducts testing procedures which may include any of the following: elevated plus maze, acoustic startle, operant conditioning, conditioned suppression, conditioned freezing, auditory and visual discrimination, radial arm maze, motor activity, open field exploration, morris water maze, predator exposure, underwater trauma, novel object recognition and others. Communicates and cooperates with Veterinary and animal care support staff to maintain and verify appropriate levels of animal care for all research animals. A high school diploma is required with experience in an animal research laboratory that includes behavioral assessment as a substantial laboratory function. Works primarily in a rodent research laboratory. Handles rodents, biological materials and a variety of laboratory equipment. Handles other species occasionally, including cat, ferret and snake. Exposure to blood borne pathogens, chemical fumes, and other hazardous agents. Department: Behavioral Biology

24. Overpressure Field Study for Theoretical and Applied Research Specialist (Key Personnel): Bachelor's degree in a technical field or 24 months of experience in a technical field research laboratory. Must demonstrate the ability to operate research equipment requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. Must possess a CPR (BLS) certification. Works primarily in a research setting. May handle biological materials and will operate lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents as necessary. Proficiency in Microsoft Office Suite programs (e.g., Word, proficiency on at least 1 computer-based statistical package; ability to collect and process research data; knowledge and ability to create computer database files for the purpose of analyses and archiving; ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology

25. Overpressure Field Study for Routine and Specialized Tests and Procedures Specialist (Key Personnel): Bachelor's degree in Psychology or 18 months of experience in a clinical research laboratory or 6 months in research setting. Ability to attach psychophysiological equipment (small electrodes, etc.) requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. CPR (BLS) certification required. Works primarily in a research setting. May handle biological materials and will operate lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents as necessary. Proficiency in most Windows programs (e.g., Word, Excel, PowerPoint); ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology

26. Experimental Sleep and Performance Study Specialist (Key Personnel): Ph.D. in Psychology with research experience in lab-based and/or field settings. At least 4 publications in the peer-reviewed literature demonstrating scientific merit of work and expertise as an experimental psychologist is desirable. Ability to attach psychophysiological equipment (small electrodes, etc.) requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. Works primarily in a sleep laboratory or in the field. Handles biological materials and lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents. Proficiency in most Windows programs (e.g., Word, Excel, PowerPoint); ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology

27. Experimental Human Stress Study Specialist (Key Personnel): Ph.D. in Psychology with research experience in lab-based and/or field settings. Requires a minimum of 3 years of research experience in lab-based and/or field settings. At least 4 publications in the peer-reviewed literature demonstrating scientific merit of work and expertise as an experimental psychologist is desirable. Ability to attach psychophysiological equipment (small electrodes, etc.) requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. Works primarily in a sleep laboratory or in the field. Handles biological materials and lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents. Proficiency in most Windows programs (e.g., Word, Excel, PowerPoint); ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology

28. Psychophysiology Relationship Investigators (Key Personnel): Ph.D. in Psychology with research experience in lab-based and/or field settings. At least 4 publications in the peer-reviewed literature demonstrating scientific merit of work and expertise as an experimental psychologist is desirable. Ability to attach psychophysiological equipment (small electrodes, etc.) requiring manual dexterity; ability to see small print on a computer monitor; ability to speak clearly; ability to hear. Light lifting and moving of equipment may be required. Must be capable of moving about and standing for long periods of time during study work shifts. Works primarily in a sleep laboratory or in the field. Handles biological materials and lab equipment. Exposure to blood-borne pathogens, chemical fumes, and other hazardous agents. Proficiency in most Windows programs (e.g., Word, Excel, PowerPoint); ability to oversee multiple tasks simultaneously; must be able to develop excellent and professional rapport with research volunteers, research assistants, and other staff members. Department: Behavioral Biology