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Howard
Private Chef
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Competencies
Demonstrated experience with Study Start-Up and Site Engagement.
Demonstrated experience with Sponsor/CRO Communication.
Demonstrated experience with TMF and eTMF Maturation.
Demonstrated experience with Regulatory Document Management (IRB, ICF, eREG).
Demonstrated experience with Clinical Site Monitoring and Support.
Education
Summary
Private Chef open to new opportunities
Experience
Clinical Research Coordinator, Oncology Melanoma Phase II Efficacious Study
Managed site-level trial operations across 4 concurrent trials, overseeing participant incentive tracking and site overhead budgeting through the OnCore platform to prevent financial discrepancies throughout each longitudinal study.. Conducted quality review meetings to align investigator site files with 21 CFR (50, 76, 312, 812) and 45 CFR (46) regulatory standards, reducing site-level deviations by 15 identified during third-party audits.. Reported Adverse Events, Serious Adverse Events, and Suspected Unexpected Serious Adverse Events via MedDRA to sponsors and review panels in a timely manner, protecting participants from ongoing trial-related and unrelated risks.. Screened patients for protocol eligibility and led informed consent discussions in accordance with HIPAA and ICH-GCP guidelines, maintaining patient-centric compliance throughout the study.
Clinical Research Coordinator, Community Research Program — HIV and STI Detailing Intervention
Evaluated site feasibility and healthcare provider readiness during initiation visits, cross-referencing interventional survey data with pilot meta-data analysis to select qualified HCPs and point-of-care sites, enrolling 10 providers per week.. Implemented a REDCap data monitoring template aligned to site personnel and client infrastructure, enabling real-time data streaming to support a risk-based monitoring approach.. Further extended academic research total office adoption liaising health care site improvement policies, recruitment strategies, clinical data platforms and financial reports with sponsors, stakeholders, and principle investigators.. Managed site regulatory packages for IRB submissions and conducted 15 quality assurance audits per quarter, removing field monitoring errors and resolving query and questionnaire discrepancies ahead of inspections.. Facilitated Sponsor-Investigator-Patient ad hoc meetings with informed consent mock trials to verify QA/QC algorithms and advance enrollment, participant compliance, and data integrity.
Associate Research Scientist, Department of Defense Immunohistochemistry and ADME
Advanced an in vivo comparative animal model pharmacokinetic R&D study to de facto phase 0 in-human trial arms, providing escalation dosage ranges demonstrating ADME effectiveness.. Enhanced protein batch validation systems including Gel Electrophoresis, PCR, BCA assay kits, and ELISA Biotinylation protocols, establishing tightened critical parameters and removing toxic contaminants in facultative aerobic hoods.. Renovated and remodeled a preexisting dosage escalation drug delivery study updating an expired registry of outdated protocol misalignments eliminating antigen anti-biotic matching discrepancies setting a quality control system set to AALAS and IACUC regulatory standards.. Extended a comprehensive biomarker panel from 30 markers to include brain memory cells and pyramidal GDNF and BDNF, augmenting a Mouse CYT ELISA Spot into a prophylactic gamma radiation pharmacodynamics study.. Logged discrepancies into computerized data repositories to capture LIMS-generated queries and errors, configuring specificity and accuracy of resolution outputs.. Specialized in developing, tracking and negotiating pre-clinical study budgets sustaining low risk high output model aligning contract expenditures with protocol standards throughout key project milestones and strict deadlines.. Implemented a compartmentalized root cause analysis and corrective action preventative action framework quantifying levels of unfavorable lipid panel antagonistic receptor protein congruency and assay templates with transparent user friend suitable platforms modified for research tech training.
Laboratory Specialist and Environmental Monitor, Multiplex Biodefense
Lyophilized proteins and separated supernatant from DNA samples, producing stabilized templates for multiplex platform assay reconstitution using precise primer, dNTP, and stock solution aliquots.. Synchronized a genotyping recombinant process of initiation, translation and conformational phases calibrating laboratory management system’s sensitive rating to evaluate the correction-error selection and identify frequency of bacterial pathogens, human genetic samples, and viral vectors.. Expanded the Genetic Bank Output database using a multi-bead chromatography platform and ABI 7000, widening the pool of virulent bacterial and viral strands for environmental quality control screening.. Piloted throughput validation techniques with QA manual reviews to optimize real-time PCR, western blot, and multi-flex bioassays for diagnostic and veterinary vector-borne pathogen tracking.
Private Chef
Delivered in-home private chef services featuring culturally diverse cuisine tailored to client expectations.. Applied food safety procedures and aseptic techniques to sanitize and prepare kitchen environments.