Clinical Research Spec 1 Req CRP & First Aid Certification (Onsite) Urgent Need

Job Title -Clinical Research Spec 1 - Req CRP & First Aid Certification (Onsite) Urgent Need

Job Location -Irvine California

Duration: 12 Months

Job Description -

Specialist 1 Clinical Operations

On Site Role
Hours: Mon-Fri 8am - 5pm

• 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 )
• Track manage and coordinate clinical study invoice processing to ensure timely review approval and payment.
• Generate reports on outstanding invoice payments for clinical study team review
• 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

• Associates/Bachelors degree in a related field
• >12 years of patient-facing experience in a clinical research healthcare or related medical setting.