Job Description

Job Title: Clinical Research Associate

Pay Rate: $32 to $40.02/Hr

Duration: 12 Months (Part-time- 20 Hours a Week)

Location: Irvine, CA

Note: Either can do 4 Hours a Day with Monday to Thursday Onsite & Remote on Friday, OR can choose to work 2.5 full Days each week.

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Research Associate. The group will be supporting advanced patient monitoring rather than Critical Care . 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, and completing associated clinical study documentation as needed.

• 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 is archived appropriately within the record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Review and ensure accuracy and completeness of clinical study files, enter into the 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
• Our people are passionate about what they do, the product they sell, and the customers they serve.
• If you're looking for an opportunity to be an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.

Top 3 Skills:

• Clinical research coordination
• Clinical study management
• Study document (e.g. ICF ) and CRF (case report form) review
• Nice to have: EDC , CTMS , Veeva (TMF), GCP training, experience with medical device studies

Requirements:

• Bachelor's Degree with 0-2 years of experience or an Associate’s degree and 4 years of relevant experience or a High School diploma and 7 years of relevant experience.
• This is a collaborative role, which requires solid communication skills and very good attention to detail.
• Good computer skills, including MS Office Suite, Adobe, and the 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

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