Clinical Operations Specialist I Part time 8am-5pm (Tues, Weds, Thurs)
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
Job Title -Clinical Operations Specialist I - Part time
Job Location -Irvine California
Duration: 12 Months
Job Description -
Part Time; On Site Role
8am-5pm (Tues Weds Thurs)Job Description:
- 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 )
- 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 CPRfor emergent needs in healthy volunteer clinical research studies
- Support clinical research laboratory operations as needed
- Other incidental duties as assigned
Required:
- At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant
- CurrentCPR andFirst Aidcertification from an accredited provider
- Able to work 3 days per week (Tuesday Wednesday and Thursday) with occasional flexibility to support full work weeks as needed
- Associates/Bachelors degree in a related field
- >12 years of patient-facing experience in a clinical research healthcare or related medical setting.
Required Experience:
IC
