• Collect data during interactions with NAP study participants• Educate and interact participants on study protocols procedures • Provides detailed and summary information and recommendations for further actions based on the data analysis• Manage clinical tests orders in patient medical records and reporting results• Monitor the administration of Sleep Apnea and Actiwatch measurements• Monitor protocols for complex research studies• Records data from biological specimens (blood and urine) and document tracking data• Conduct blood smears, centrifuging, and EEG procedures per study protocol• Analyzes processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations• Prepares project and statistical reports for review process• Oversees, screens, and evaluates recruitment of candidates for clinical research studies via telephone and/or in person.• Uses objective assessments and questionnaires to identify potential candidates• Performs informed consent process throughout the study• Performs daily study activities related to participant interviews and follow-up visits• Conduct and coordinates study participant randomization to treatment, works closely with the Research Pharmacy, study leadership, and investigators on study drug provision• Assists supervisor with managing the routine, day-to-day activities, and administration of the project• Completes and submits required documentation/forms for initial, continuing human subject's review, AE, and unexpected problems to the regulatory committees• Conducts quality assurance evaluations for project data and clinical research instruments. Establishes and monitors remediation plans to correct deficiencies.• Compiles and produces educational and training materials; determines contents needed for training binders and tools

• • Support clinical research studies and maintain a safe study environment according to health and safety policies under the direction and delegation of the Principal Investigator• Safeguard the well-being of subjects, act as a volunteer advocate, and address subject’s concerns • Maintain up-to-date study protocols, case report forms (CRFs), Electronic Data Capture (EDC) systems, and other study documents• Plan and coordinate logistical activity for study procedures according to the study protocol• Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, inventory of required supplies, and setting up or troubleshooting equipment and/or study issues• Assist with data entry, data quality checking, and query resolution to ensure adherence to study protocol and quality control for content accuracy and completeness• Assist in study enrollment by recruiting, screening, and orienting volunteers according to the study protocol• Correct custody of study drug according to site standard operating procedures• Perform inclusion/exclusion, write source documents according to the study protocol• Coordinate with study monitor on study issues and effectively respond to monitor-initiated questions• Draft detailed and summary reports for presentations at meetings, conferences, and peer reviewed journals

• Patient visits, laboratory assessments, and proper source documentation• Investigational product shipping, handling, dispensing, administration, and accountability• Observed study budgeting, contracting, and start-up• Familiarized with protocols and following schedule of events (SoE)

• Fill prescriptions according to orders• Order for Pharmacy• Inventory of control• Customer Service/ get prescription ready for mail orders or delivery

1. Clinical Trial Operations 2. ICH GCP E6 (R2) Guidelines and FDA Regulations 21 CFR Parts 11, 50, 54, 563. GDP following ALCOA-C principles4. Protecting rights of the patients5. Informed consents process6. Regulatory Affairs7. Identification and reporting of AEs and SAEs8. Quality Assurance, Inspection, Monitoring and Query Resolution9. Comprehension and Execution of Clinical Trial Protocols10. Informed Consent Process11. Data Management Systems, Electronic Data Capture (EDC) systems like MedRio, Medidata, InForm12. Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibilities and duties)13. Maintaining regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA14. Training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF)15. Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF), and other Investigator Site File (ISF) documents16. Medical Terminology, Clinical Trial Training

• Testing of Raw materials, in-process, finished products, outside vendors, stability and validations samples • Perform monthly/daily calibrations on lab equipment• Development auditing of procedures, work instruction to comply with cGMPs, EU, OSHA, and EPA regulatory requirements• Assist with chemistry training, support, and expertise to In-Process, Finish Product, Raw Materials, and Stability testing• Able to perform investigations, open reports, and follow-up on Chemistry related quality issues• Perform validation protocols, including sanitations and new equipment• General chemical testing utilizing a variety of scientific techniques and laboratory instruments• Complete testing according to USP, FCC, EP methods, SOPs, test methods, and cGMP requirements• Review and release of laboratory documents • Able to perform and train in Finished Product testing of Microbiology samples• Able to perform environmental testing using Air Sampler, swabs, and filtration techniques.• Able to perform tests on HPLC, GC, UV/VIS, FT-IR, Karl Fisher, Polarimeter, Particle Size Analyzer, and Autotitrator

• Knowledge of GMP requirements and Microbiology Laboratory and microbiological analytical knowledge in a pharmaceutical environment• Prioritize and manage day to day analytical testing, strong attention to detail, ability to meet deadlines• Follow written procedures like SOPs and Analytical procedures• Perform various microbiological testing procedures like media qualifications sterilizations, growth promotion tests, identification tests • Perform and support laboratory activities like media preparation, cell culture, monitoring of incubators, write and review SOPs, quality notifications, maintain documentation • Aware of the current scientific principles and theories • Recognize and report any aberrant test and/or sample conditions • Contribute in investigations and system/procedures development

• Training in High Content Screening methods• Assay development for glucose stimulated insulin secretion (GSIS)• Cell Culture of Sum-149 cells & INS-1 Cells • Cell Culture of HB-126 Hybridoma for cell banking, propagation and monoclonal antibody production • Write SOPs according to cGMP, and conduct all assigned activities in a safe and cGMP compliant manner

• Cell culture and maintenance of HT22 and NS-1 cells • Protein purification• SDS-PAGE Electrophoresis• Western blotting• Viability assays (MTT, LIVE-DEAD)• ELISA• Cell fractionation (isolation of organelles such as Mitochondria, ER)• Cell sorting• Flow Cytometry

• EGF stimulated Erk5 Phosphorylation studies • Maintenance & Passage of MDA-MB-231 cells• Preparation & Execution of compound treatments & stimulation • Harvesting of materials • Protein determination• SDS-PAGE• Western Blotting• Sequential probing for phospho-Erk5 & Total Erk5• MEKK2 Domains expression in SF9 cells• Maintain cells for baculovirus expression of selected kinase domains (MEKK2 & Bir A)• Static culture• Suspension Culture• Western Blotting using affinity probes nickel & Biotin conjugates• Assed methods for stripping nickel affinity probes from Western Blots• EDTA Imidazole