DBSI
Clinical Project Engineer- Medical Device
DBSI, Foothill Ranch, California, United States, 92610
Clinical Project Engineer
Location: Lake Forest, CA Job Description & Skill Requirement: Key Responsibilities: Supporting the team to design, plan and develop clinical evaluation research bench studies. Supporting to conduct registered and non-registered non-clinical bench studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Supporting to assist in interpretation of results of non-clinical investigations in preparation for new drug, device or consumer application. Supporting the team to resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and prepare clinical trial budgets and responsible for clinical supply operations, site and vendor selection. 1. Site Selection and Initiation: Assist in the selection of investigative sites for clinical trials. Conduct site initiation visits to train and educate site staff on the study protocol, regulatory requirements, and proper handling and storage of ophthalmic drugs and medical devices. Ensure recruitment strategies are in place to meet enrollment targets. 2. Monitoring and Site Management: Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance. Review source documents, case report forms, and patient records. Verify the informed consent process and adherence to the study protocol. Ensure that instruments/equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards. Collaborate with Clinical Operations Lead and Clinical Trial Team to identify and resolve site quality or study execution issues. 3. Regulatory Compliance: Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP) regarding ophthalmic drugs and medical devices. Ensure that the Investigator Site File is maintained and audit ready. 4. Investigational Product and Clinical Supplies Oversight: Verify subject qualification and correct IP was dispensed/implanted. Confirm full reconciliation of IP at the site level. Monitor device-related safety and performance concerns and report them to the study sponsor. Ensure proper handling, storage, and accountability of investigational drugs and/or medical devices. Ensures appropriate clinical supplies are available and adequate for clinical trial. 5. Data Management: Verify data accuracy and completeness, including instrument/device-generated data. Collaborate with data management team to resolve data-related issues. 6. Safety Reporting: Ensures all safety issues are communicated and managed by Principal Investigator according to regulatory and protocol requirements. 7. Close-Out Visits: Conduct close-out visits to finalize data collection and ensure all study-related activities are completed in accordance with the study protocol and regulatory requirements. 8. Documentation and Reporting: Complete comprehensive and accurate monitoring reports, including site follow-up letters. Ensure CTMS and eTMF are up to date and audit ready. Compensation: $90,000.00 - $100,000.00 per year
Location: Lake Forest, CA Job Description & Skill Requirement: Key Responsibilities: Supporting the team to design, plan and develop clinical evaluation research bench studies. Supporting to conduct registered and non-registered non-clinical bench studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Supporting to assist in interpretation of results of non-clinical investigations in preparation for new drug, device or consumer application. Supporting the team to resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and prepare clinical trial budgets and responsible for clinical supply operations, site and vendor selection. 1. Site Selection and Initiation: Assist in the selection of investigative sites for clinical trials. Conduct site initiation visits to train and educate site staff on the study protocol, regulatory requirements, and proper handling and storage of ophthalmic drugs and medical devices. Ensure recruitment strategies are in place to meet enrollment targets. 2. Monitoring and Site Management: Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance. Review source documents, case report forms, and patient records. Verify the informed consent process and adherence to the study protocol. Ensure that instruments/equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards. Collaborate with Clinical Operations Lead and Clinical Trial Team to identify and resolve site quality or study execution issues. 3. Regulatory Compliance: Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP) regarding ophthalmic drugs and medical devices. Ensure that the Investigator Site File is maintained and audit ready. 4. Investigational Product and Clinical Supplies Oversight: Verify subject qualification and correct IP was dispensed/implanted. Confirm full reconciliation of IP at the site level. Monitor device-related safety and performance concerns and report them to the study sponsor. Ensure proper handling, storage, and accountability of investigational drugs and/or medical devices. Ensures appropriate clinical supplies are available and adequate for clinical trial. 5. Data Management: Verify data accuracy and completeness, including instrument/device-generated data. Collaborate with data management team to resolve data-related issues. 6. Safety Reporting: Ensures all safety issues are communicated and managed by Principal Investigator according to regulatory and protocol requirements. 7. Close-Out Visits: Conduct close-out visits to finalize data collection and ensure all study-related activities are completed in accordance with the study protocol and regulatory requirements. 8. Documentation and Reporting: Complete comprehensive and accurate monitoring reports, including site follow-up letters. Ensure CTMS and eTMF are up to date and audit ready. Compensation: $90,000.00 - $100,000.00 per year