Clinical Project Engineer- Medical Device
Full Time • Lake Forest, CA
Benefits:
- 401(k)
- 401(k) matching
- Relocation bonus
Title: Clinical Project Engineer
Location: Lake Forest, CA
Job Description & Skill Requirement:
Key Responsibilities:
Job Description & Skill Requirement:
Key Responsibilities:
- Supporting to 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 to 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.
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
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