Chang Shim Email & Phone Number

Irvine, CA, US

San Diego, California, United States

San Diego, California, United States

• Responsible for biospecimen sample routing, tracking, and query resolutions between clinical sitesand the central lab and CROs.
• Responsible for planning, coordinating, and tracking biospecimen shipments (PK, biomarkers)between central lab and specialty vendors.
• Responsible for oversight of long-term biospecimen management.
• Assist in drafting and reviewing clinical study protocols for sample collection requirements andalignment with the SOW (PK, biomarkers), study lab manuals, and relevant company policies.
• Assist in ensuring the availability of clinical trial supplies related to biospecimen collection,processing, shipment, and storage.
• Work cross-functionally to assist in implementing regulatory and compliance efforts regardingthe collection and analysis of clinical samples, including HIPAA requirements, privacy policies,and chain of custody.

Orange County, California Area

• Identify and screen potential study subjects working with the treating physician and the clinical care team.
• Collaborate with the principal investigator on the patient consenting process and document the process following internal guidelines and GCP standards.
• Manage all aspects of monitoring visits and prepare information to meet the sponsor’s needs and address them promptly.
• Analyze the service requirement, resources, and equipment availability for the Chao Family Comprehensive Cancer Center research lab and other satellite sites.
• Evaluate the gaps or barriers and provide feedback to ensure adequate study budgeting specific to the lab activities of the research protocols.
• Provide critical response in an operational meeting with ancillary groups that the Cancer Center interfaces with for the conduct of clinical trials.

Orange County, California Area

Orange, California

Columbus, Ohio Area

• Processed research and clinical histology specimens using approved protocols and instrumentation.
• Processed clinical blood samples and performed quality control on the final product.
• Performed special staining, in situ hybridization, and immunohistochemistry assay utilizing new antibodies for an automated IHC system.
• Researched new antibodies and managed the interaction and coordination between the Department of Pathology Core Facility and the pharmaceutical group.
• Valid new equipment and completed monthly maintenance to be up to date on the hospital standard.
• Serve as a safety officer and update the chemical hygiene plan for the team.

• Prepares supplies for specimen collection, processing, storage, retrieval, and shipping.
• Manages database using written and computer format.
• Performs inventory management and quality control for sample processing.
• Keeps laboratory maintenance records; orders needed supplies.
• Review amendments issued on current clinical trials; assist others with updating processing instructions and date calendars.

Columbus, Ohio

• Perform complex laboratory services and special procedures, including component reconciliation, production record review, and split plateletpheresis products according to established procedures.
• Perform component supervisory functions associated with component manufacturing and processing.
• Act as resources for other laboratory services staff regarding component production, quarantine and labeling, equipment quality control, and waste management of blood products.
• Serve as team or shift leader and train other staff. Other tasks include performing quality control on blood products. Maintain accurate, legible, and complete production and testing records.
• Perform data entry and operate the computer programs associated with component production, labeling, and storage. Manufacturing procedures meet the standard of FDA regulations.