About this opportunity
MillenniumSoft Inc lists this Clinical Operations Spec 1 - Onsite (Must at least 2 yrs in clinical research exp) opportunity in irvine, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Location
17200 Laguna Canyon Road, Irvine, California, United States of America, 92618
Duration
12 Months
Job Title
Spec 1, Clinical Operations
Number of Positions
1
Job Description -
Specialist 1, Clinical Operations
On Site Role
Hours: Mon-Fri, 8am - 5pm
Pay Rate - $35 - $40/hr (pay rate will be determined at time of offer)
Must have at least 2 years in clinical research experience
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.
Coordinate procurement of study inventory and manage shipment of devices to clinical sites within established timelines.
Confirm receipt of study product at clinical sites and tracks product through to final disposition; ensuring required documentation are filed in the Trial Master File (TMF).
Monitor internal device and study-specific inventory levels; support inventory forecasting and planning. Develop timeline assessments in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
Generate transparency reporting data and reports as needed to support Sunshine Act compliance.
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
Ensure documentation are stored and archived appropriately within record retention facilities (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
Support clinical research laboratory operations as needed
Other incidental duties as assigned to support clinical study operations
Required
>2 years of clinical research experience
Preferred Experience/qualifications
Associate's/Bachelor’s degree in a related field
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Worksite address
irvine, CA, 92713, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.