Clinical Research Specialist 1 - Req 2 yrs Exp in Clinical Research & Regulated Industry) Onsite

Millenniumsoft; Irvine (CA); On-site; USD 73,000 - 83,000; Full time

Job summary

MillenniumSoft Inc. in Irvine, CA seeks a Clinical Research Specialist 1 for a 12-month contract on W2. The role focuses on clinical trial device processes, regulatory compliance, and collaboration with study teams, manufacturing, quality, and finance to drive trial timelines.

The position is Mon-Fri, 8am-5pm, 40 hours/week, with a pay rate of $35-$40 per hour. First shift, on-site in Irvine. Requires 2 years of clinical research experience and an associated degree.

Qualifications

• 2 years of clinical research experience.
• Associate's or Bachelor's degree in a related field.

Responsibilities

• Identify, develop, recommend, and implement, moderately complex 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, while partnering with internal stakeholders to execute the device process.
• 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 track through final disposition; ensure required documentation are filed in the Trial Master File (TMF).
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning with clinical stakeholders.
• Generate transparency reporting data to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing; generate reports on outstanding payments.

Skills

Clinical research experience

Education

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

Job description

• 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