We are hiring Clinical Research Associate -I!.
Our Large Medical Device Manufacturing Client is looking for Clinical Research Associate - I in Irvine, CA.
Please let me know if you are interested or anyone who might be interested.
Job Details:
Client: Large Medical Device Manufacturing Client
Location: Irvine, CA
Title: Clinical Research Associate - I (Part-Time)
Duration: 9 Months
Hourly Rate: $30.00-$40.00/ Hour on W2 ONLY
20 Hours/Week - Part-Time Role
What does your group do? Clinical Affairs - Support clinical research initiatives within Critical Care business unit.
Does your team use any specific technology/software you want us to look out for? JDE, Sharepoint, MS Office Suite, EDC, TMF, CTMS
More on this position:
What will a typical workday look like? Clinical study device management activities such as ordering devices, coordinating international and domestic shipments, facilitating the return of study devices and equipment, managing clinical study and research laboratory device inventory, completes associated clinical study documentation as needed.
This is a collaborative role, which require solid communication skills and very good attention to detail.
Will there be any travel involved? Travel is not required for this position but may occur with agreement from both parties.
What are your top 3 required technical skills? Must haves? Preferred technical skills: Clinical research coordination, clinical study management, study document (e.g. ICF) and CRF (case report form) review
What are nice to have skills ? EDC, CTMS, Veeva (TMF), GCP training, experience with medical device studies
Is there anything that would automatically disqualify a candidate? No prior clinical research experience
What you will do:
• 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 in JDE and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and Warehouse.
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 assessment (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
• 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.)
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned
Additional Skills:
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast paced environment
• Strict attention to detail
Minimum Education and Experience:
• Bachelor's Degree
• 0+ years of experience
Best regards,
Vishnu Das Natesan (Vish)
|Direct Phone: 609-948-7499 | Email ID: dvishnu@radiants.com
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