Clinical Research Specialist 1 - Req 1-2 Years Exp in patient-facing and Clinical Research (Onsite)

millenniumsoft•Irvine, CA

8d•Onsite

About The Position

This is an on-site role in Irvine, California, for a Clinical Research Specialist 1. The position is for a duration of 12 months, with working hours from Monday to Friday, 8 am to 5 pm. The specialist will be responsible for identifying, developing, recommending, and implementing process development and improvement solutions to optimize global trial workflow timelines. This includes managing device return aging issues and the status of open device issues/queries. The role involves developing and executing device processes for clinical trials, ensuring regulatory compliance, and managing the device lifecycle. Collaboration with internal stakeholders such as clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups is crucial for developing and executing device processes and driving continuous improvement. The specialist will also verify inventory, process device shipments to clinical sites within established timeframes, confirm product receipt with clinical sites, and obtain signed packing slips. Monitoring device inventory in coordination with Supply Chain and Clinical Specialists, developing timeline assessments for system transitions and enhancements, and ensuring appropriate archiving of documentation are key responsibilities. Additionally, the role includes tracking, managing, and coordinating clinical study invoice processing, generating reports on outstanding payments, and reviewing clinical study files for accuracy and completeness before archiving. Support for clinical research laboratory operations and other incidental duties may also be required.

Requirements

1-2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.

Nice To Haves

Associate's/Bachelor’s degree in a related field.

Responsibilities

Identify, develop, recommend, and implement process development and process improvement solutions to optimize global trial workflow timelines.
Develop and execute device processes associated with clinical trials.
Ensure compliance with regulations and manage the lifecycle of devices.
Partner with internal key stakeholders to develop and lead the execution of the device process.
Ensure continuous process improvement of efficiency and accuracy of processes and procedures.
Verify inventory and process device shipment to clinical sites within our shipping timeframe.
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 in collaboration with clinical stakeholders to meet key study milestones and deadlines.
Ensure documentation are archived appropriately within record retention facility.
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.
Support clinical research laboratory operations as needed.
Other incidental duties as assigned.