Michael Jorgensen Email & Phone Number

Durham, North Carolina, Us

Cambridge, Ma, Us

Sample Tracking & Logistics/Data Reconciliation:- Responsible for tracking clinical patient samples across four different clinical trials at various stages- Perform monthly reconciliation of cumulative inventory and data files from multiple external vendors across three different studies to flag any discrepancies in the data or missing samples- Received and accessioned temperature-sensitive patient samples into LIMS system, taking special care to ensure appropriate temperature was maintained during accessioning process to preserve sample integrity- Accessioned and tracked external samples going from initial clinical site to external vendors in internal system for easier tracking- Attended weekly calls with external vendors to trigger batch shipments of samples from central lab to other vendors where sample analysis is performed as well as ensure samples aren’t stagnating and get to labs in a timely fashion with internal company timelines in mind- Upload vendor files into secure SFTP serverUser Acceptance Testing:- Acted as the lead for multiple UATs including reviewing Production Issues Log and DVS, drafting the test plan and assigning tasks to different testers- Write test scripts for UATs being performed on new or updated data systems- Execute test scripts to see if changes in database behave as expected, and record findings in production log- After completion, filed all relevant finalized documents into appropriate eTMF folderReport and Metrics Generation:- Generated reports of at site clinical samples to provide to the Clinical Operations team to ensure all patient samples from clinical trials reach downstream vendors and central lab for storage and analysis- Using Python, created graphical metrics to compare study start-up data across all internal studies to visualize efficiency and view trendsExternal Vendor Management:- Attended weekly or biweekly status update calls with external vendors and CROs as Jounce's Data Management representative

Cambridge, Ma, Us

- Performed a wide variety of wet lab assays including Antibody-Dependent Cellular Cytotoxicity (ADCC), Complement-Dependent Cytotoxicity (CDC), Platelet Activation, Whole Blood Soluble Format Cytokine Release, ELISA development, and Pseudovirus Neutralization.- Analyzed data and entered results from all experiments into an Electronic Lab Notebook (ELN)- Drafted sections in IND filings for safety experiments performed on discovery-phase antibodies with the goal of entering the clinic.- Performed Mammalian cell culture to maintain cell banks.- Because of a shortage of biological materials as a result of the COVID-19 pandemic, worked with IT and research leadership to develop a healthy donor PBMC request system to ensure that there were enough PBMCs available for priority projects so company yearly goals could still be attained.

Cambridge, Ma, Us

Cambridge, Ma, Us

Us

In preparation for the hospital's Go-Live with the Epic software, learned all aspects of the Beaker Laboratory application (both anatomic and clinical pathology modules) and was responsible for leading classes, reviewing lesson plans, and practice workbooks to ensure that they paralleled Mount Auburn's specific workflows. A strong understanding of Medical Technologist, Lab Processor, Customer Service, Phlebotomy, Microtechnology, Supervisor, Gross Assistant, Histotechnology, Cytology, and Pathology workflows were necessary in order to effectively communicate the lessons to the hospital lab staff. Acted as floor support for Beaker end users after Go-Live date, as well as for the Outpatient (Ambulatory) application.

Cambridge, Massachusetts, Us

Responsible for receiving, storing, and tracking clinical samples in a GCLP facility in compliance with GLP and GCP provisions. Also responsible for processing incoming fresh tissue needle biopsies and resections into FFPE blocks, H&E staining of clinical sample slides, as well as scanning and imaging of stained slides after returning from pathology review. As the lab's equipment manager, tasked with seeing new equipment through validation process, as well as keeping up with the calibration/PM schedules for every piece of equipment in the lab.

Beverly Hills, California, Us

During events, ensured that all guests and staff were safely enjoying themselves by providing excellent customer service, risk assessment, ID checking, and pat-downs when necessary as well as periodically checking fire lanes and other parts of the venue. Also assisted in set up and break down before and after the event.

Boston, Ma, Us