About the role
Position : Clinical Research Specialist 1 Location : Irvine, CA Duration : 12 Months 1st Shift Total Hours/week : 40.00 Client : Medical Devices Company Job Category : Clinical Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT Hours: Mon-Fri, 8am - 5pm
Pay Rate - $35 - $40/hr (pay rate will be determined at time of offer)
Job Description
- 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
- Associate's/Bachelor’s degree in a related field
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at MillenniumSoft Inc was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.