Clinical Project Engineer- Medical Device
Listed on 2026-01-12
-
Healthcare
Clinical Research, Medical Science
Clinical Project Engineer
- Medical Device
Full Time
• Lake Forest, CA
- 401(k)
- 401(k) matching
- Relocation bonus
Lake Forest, CA
Job Description & Skill RequirementsKey Responsibilities:
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.
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.
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.
Verify subject qualification and correct IP dispensed/implanted; confirm full reconciliation of IP at 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; ensure appropriate clinical supplies are available and adequate for clinical trials.
Verify data accuracy and completeness, including instrument/device-generated data; collaborate with data management team to resolve data-related issues.
Ensure all safety issues are communicated and managed by Principal Investigator according to regulatory and protocol requirements.
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.
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 - $ per year
MAKING THE INDUSTRY’S BEST MATCHESDBSI Services is widely recognized as one of the industry’s fastest growing staffing agencies. Thanks to our longstanding experience in various industries, we have the capacity to build meaningful, long‑lasting relationships with all our clients. Our success is a result of our commitment to the best people, the best solutions and the best results.
Our StoryFounded in 1995
Privately Owned Corporation
Managing Partner Business Model
Headquartered in New Jersey
US Based Engineers Only
Methodology and Process Driven
Top performing engineers are the foundation of our business. Our priority is building strong relationships each employment candidate we work with. You can trust our professional recruiters to invest the time required to fully understand your skills, explore your professional goals and help you find the right career opportunities.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).