Natalie Kwiatkowski

• Adheres to safety and clean area procedures to comply with agency and regulatory mandates.
• Performs quality control of raw data, identifies data entry errors, and reports to necessary departments.
• Places holds on lab samples that do not follow GLP.
• Creates new orders and enters patient data on Laboratory Inventory Management System (LIMS).
• Provides necessary checks to ensure proper accessioning.
• Ensures that information in LIMS is up-to-date.
• Protects patient health information (PHI) at all times to ensure compliance with HIPAA and privacy policies.
• Performs safe and proper handling of samples (tissue, buccal, and blood).
• Maintains familiarity with standard operating procedures (SOPs) and quality standards determined by the clinical laboratory.

• General Duties: Administration of assessments and scales, obtaining informed consent, obtaining medical history, assessing vitals, performing physical exams, confirming eligibility, managing ePROs.
• Working in adherence with study protocols and institutional SOPs.
• Possessing IATA Dangerous Goods certification.
• Processing lab samples, preparation and packaging of study lab samples for shipment, compliance to regulations of electronic signatures 21 CFR part 11, AE/SAE reporting, detecting safety events.
• Writing of CAPA plans.
• QC of study visit documents for sponsor and external agencies.
• Participation in sponsor and external agencies audits and visits.
• Maintenance of SOPs.
• Writing of participant visit-report summaries.
• Raw data entry into EDC.
• Assessment and submission of protocol and SOP deviations.
• Compliance to GCP and GDP regulations.
• Overseeing calibration of equipment for studies.
• Involved Studies: 405-201-00016/17/21, BHV3000-311, TV48125CNS30082/3/4, 3110-305-002, LND300, REL1017-301/310, NAV17A-007, 54135419TRD4005, 3112-301-001, 3070-301-001, MindMed008, BHV4157-302/209, 2021-PT054.
• Administered clinical assessments such as MINI-KID, MINI, IDS-C 30, SCID-5-CT, MGH-ATRQ, CGI–S, CGI-C, CGI-I, C-SSRS, Y-BOCS, YMRS.
• Administered self assessments for participants such as DSST, SDS, PGI-S, PGI-C, PedMidas, PedsQL, PQ-LES-Q.

• Administration of PHQ-9 and GAD-7 behavioral questionnaires to patients.
• Documentation of patient's results in EMR.
• Review of scores for determination of upcoming questionnaire follow up.

• Teamed with other physicians, specialists, and health care providers to provide well-rounded care for complex cases.
• Evaluated patient histories, complaints, and current symptoms.
• Engaged with other professionals to impart knowledge and discuss best treatment courses.
• Monitored post-operative recovery and educated patients on at-home recovery.
• Administered high level of care to patients using active listening and open-ended questioning.
• Collected blood samples, utilized Siemens RapidPoint 500 blood gas analyzer.
• Followed proper procedure for installation and removal of catheters, IV's.
• Performed routine wound care and dressing changes on schedule.

Laboratory Assistant

Medical University Of Bialystok – Bialystok, Poland

● Obtained samples for testing, adhered to OECD GLP and GDP.

● Reviewed documentation.

● Prepared blood smears and determined levels of normalcy.

● Prepared tissue specimens for routine and special procedures.

● Embedded, cut and stained tissue for histologic examination.

● Prepared samples for shipping and disposed of bodily fluids in proper containers.

● Maintained instruments such as the Mastercycler Nexus, TN5000 manual microtome, and Beckman Coulter Alifax Test 1 ESR analyzer to keep equipment fully operational.

● Utilized autoclaves on equipment to maximize purity of specimens.