My responsibilities included laboratory work using extreme microorganisms to improve soil quality and increase crop yields. This experience required me to be proactive, creative and analytical in evaluating results and provided me with a broad knowledge of microbiology through the mentorship of the Puna Bio team and IndieBio's distinguished community. This occurred during IndieBio's Cohort 12 launch acceleration program, centered on science and biology-based startups. This experience effectively bridged the gap between science and business in my mind.

Managed Clinical Research Associate activities on cardiac device studies in compliance with Good Clinical Practices and appropriate FDA regulatory standards.~ Served as liaison between field CRAs and site for study activities; performed remote site activations for study start-up, to site follow-up throughout study duration, to executing site close-out; escalate concerns to project management when necessary. Requested documents and reviewed data for successful closure of monitoring visit findings.~ Activated and managed sites from study start-up, through study close-out activities.Received a commendation award for site activation into 3 different protocols, working to meet each study activation timeline for that month. ~ Collected and edited essential trial master file documents, reviewed for monitoring visits to be aligned with the Monitoring Plan. Edited informed consents to ensure all essential elements are included at site start-ups, protocol amendments, and study renewals.~ Reviewed essential documents to align with Trial Master File and for an inspection-ready state.~ Monitored data remotely for completeness with a focus on data integrity and patient safety. Reviewed data, issued, and closed queries in Medidata Rave and Oracle electronic database for study data accuracy and completeness to study protocol.~Prepared SAE and death narratives for annual and final reports, submitted device complaints, escalated key compliance issues notifying site and project management.~ Maintained the quality of clinical deliverables, addressing issues with team members.~ Approved study invoices according to Clinical Trial Agreement and approved quarterly site exceptions payments for timely study site payments throughout duration of the study.~ Participated in training offered to increase therapeutic knowledge.

Managed spinal cord stimulation device trials as a Clinical Trial Associate according to Good Clinical Practice and FDA regulatory practices.~ Co-monitoring activities with field CRAs when needed.~ Presented meetings and trained clinical team on SOPs, operational updates to clinical work instructions and processes.~ Led monthly SOP/Clinical Operations meetings, updated clinical team of outdated clinical operational practices and changes to clinical SOPs, work instructions and processes. ~ Generated a streamlined SOP approval process of clinical documents, trained clinical team on standardized process of approval between the Trial Master File and the CTMS systems.~ Collaborated in drafting informed consent forms, and participated in CRF development to incorporate edit-checks.~ A Subject Matter Expert on clinical essential documents in alignment with TMF and CTMS.BIMO preparation, participation, and resolution.~ Received a commendation award for remediation activities, in developing a Trial Master File, and reviewing clinical documents for 5 sites for the success of a BIMO inspections audit.~ Approval of CRA expense reports to be aligned with sponsor company SOPs.~ Approval of essential documents to be aligned with TMF and CTMS.~ Data and discrepancy resolution in Netregulus and Medidata Rave EDC~ Prepared study supplies and binders for shipment to sites for SIVs and ad-hoc as requested by sites.

Involved research areas:- Biological barriers in pulmonary delivery for Cystic Fibrosis- Role of a serum protein in LNP-mediated mRNA expression- Bioanalytical characterization of LNP delivery in serum- Supported other tasks such as tissue processing from in vivo studies and protein production.