Spec 1, Clinical Operations

Immediate need for a talented Spec 1, Clinical Operations. This is a 12 months contract opportunity with long-term potential and is located in Irvine, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-09454

Pay Range: $27 - $37/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips.
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned

Key Requirements and Technology Experience:

• Key Skills;At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant.
• 2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials.
• Associate's/Bachelor’s degree in a related field 
• >1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.

Our client is a leading Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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