Working for ICON as a Clinical Study Administrator providing support for clinical trials with Biosense Webster at Johnson & Johnson Medical Devices-Experienced with working with the clinical study team on different project spanning 30+ sites including OUS centers and 200+ patient enrollment targets along various stages, including study start up, enrollment, close out and submission.-Key member of the clinical operations group as part of the cross functional core team for deliverables for IDE submissions and deficiency responses, including development of clinical protocols, review of IDE submission documentation and development/oversite of other central trial documents such as eCRFs, ICFs and Committee Charters.-Tasked with maintaining internal and regulatory inspection readiness, including but not limited to, ensuring device accountability, ensuring sponsor/site training, providing critical study metrics, and maintaining all study documentation in accordance with good documentation practices. -Experienced with regulatory body audits, including FDA BIMO and PMDA inspection preparation and successful completion without deficiencies.-Tasked with working with clinical teams in the US, Europe, Japan and China on regulatory body submissions and inspection readiness.-Responsible for vTMF/OneCTMS management, ensuring good documentation practices, audit/inspection readiness, and upkeep of critical clinical study documentation, metrics, and reports.-Key member in the review and maintenance of site and sponsor documentation, including device accountability, central trial documents, IRB submissions/approvals, site/sponsor personnel trainings/certifications and delegation logs.-Responsible for working with multiple departments such as Data Management, Biostatistics and Programming on endpoint derivations, disposition mapping, TFLs, and device and patient database development to ensure proper data compliance, clean up and for reporting.

Facilitate and assist QC/Documentation, Pathology, Project Management and Logistic departments in tackling clinical trial timelines and client projects through administrative support including;-Creation of Takedown/Evaluation paperwork for clinical/in-house samples.- Adhering to project timetables and prioritization of aggressive client timelines.-Updating project trackers and client/in-house sample documentation.-Barcoding and QC stained samples-Assisting and resolving discrepancies and adhering to internal and client standards of accurate and detailed documentation.-Preparation and compliance with internal and client audits.-Assisting with administrative duties such as filing and documenting paperwork-Adhere to and maintain good working knowledge of GCP and GDC

Aided MRI technicians, nurses, physicians and respiratory therapists for the duration of MRI examinations at Sharp Memorial and Rady’s Children’s Hospital. Provided monitoring assistance and direct patient care to both emergent and non-emergent cases. Participated in screening research study patients and administering relevant examinations. Experienced in chart interpretation, patient screening, and facility safety.-Implemented new workflow management, employee training and safety protocol, decreasing incident rates and increasing patient satisfaction.-Responsible for the education and the discussion of potential MRI examinations including inclusion and exclusion criteria as well as following hospital protocol in obtaining proper documentation and consent.-Accessed and interpreted various patient medical records and confidential information with discretion through various systems such as Cerner, Synapse and E.P.I.C to ensure patient confidentiality and eligibility for examinations.-Conducted responsible patient care practices in accordance of scope of practice (ie. vitals signs, medical history screening, and limited assistance and monitoring with intubated, trauma, anesthesia and stroke code patients)

Developed medical innovation presentations and studies to present at various medical conferences with special attention to AI, big data, deep learning and various other technology implementation. Shadowed physicians and interviewed staff and influential individuals such as author Eric Topol and Dr. Marty Kohn. Responsible for abstract proposals and spreading awareness of technological innovations and companies to be implemented in healthcare.-Selected as a lead intern for the program and implemented mentor sessions and various guest speakers to interact to interns in the program.-Worked within a research team to investigate social media’s impact on inpatient children.-Presented at MI2 conferences, Grand Rounds and assisted with the AI+MD conference.

During summer worked as a job pack puller, packing tiles into pallets and getting them ready to ship. Gained hands on experience on the demands and environment of physical labor

Volunteer for Kaiser Permanente as information desk and patient care volunteer. Provided assistance to patients and families within volunteer scope of practice.