Spec 1, Clinical Operations

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

Job summary

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Research Specialist 1 for a 12-month contract on 1st shift, 40 hours per week. Onsite position with a pay rate of $35–$40 per hour, to be determined at offer stage.

The role focuses on developing and implementing process improvements for global trial workflows, coordinating device-related activities, TMF documentation, and invoice management while ensuring regulatory compliance of device trials.

Qualifications

• 2 years of clinical research experience.
• Associate's/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, ensuring regulatory compliance and lifecycle management of devices.
• 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 to final disposition, filing TMF documentation.
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning; develop timeline assessments with stakeholders to meet milestones.
• Generate transparency reporting data and reports as needed to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing and report outstanding payments.
• Ensure documentation are stored and archived appropriately within record retention facilities.
• Review and ensure accuracy and completeness of clinical study files and enter into tracking systems.
• Support clinical research laboratory operations as needed.
• Other incidental duties as assigned to support clinical study operations.

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