Clinical Research Specialist 1 (Req 1-2 Yrs Patient-Facing Exp)

MillenniumSoft Inc; Irvine (CA); On-site; USD 34,000 - 49,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Clinical Research Specialist 1 for an Irvine, CA engagement. This entry-level, on-site contract role supports patient-facing activities within clinical trials and device-related studies, coordinating with cross-functional teams to meet study milestones.

You will help implement process improvements, ensure regulatory compliance, and manage device lifecycle documentation, inventory, and invoicing. Work hours are 40 per week, Monday–Friday, 8am–5pm.

Qualifications

• 1-2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
• Associate's/Bachelor’s degree in a related field (preferred).

Responsibilities

• Identify, develop, and implement moderately complex process development and process improvement solutions to optimize 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 stakeholders to execute the device process and improve efficiency.
• Verify inventory and ship devices to clinical sites within shipping timeframes to relevant stakeholders.
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists.
• Develop timeline assessments in collaboration with clinical stakeholders to meet study milestones.
• Ensure documentation is archived appropriately within record retention facilities.
• Track, manage, and coordinate clinical study invoice processing for timely review and payment.
• Generate reports on outstanding invoice payments for clinical study team review.
• Review and ensure accuracy of clinical study files and archive them.
• Support clinical research laboratory operations as needed.
• Other incidental duties as assigned

Skills

Patient-facing experience

Clinical research

Regulatory compliance

Documentation

Education

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

Job description

Position : Clinical Research Specialist 1 (Req 1-2 Yrs Patient-Facing Exp)

Location : Irvine, CA

Duration : 12 Months

1st Shift

Total Hours/week : 40.00

Client : Medical Devices Company

Job Category : Clinical

Level of Experience : Entry Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

$30/hr

On Site Role

Hours: Mon-Fri, 8am - 5pm

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.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• 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 (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• 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

Required

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

Preferred Experience/qualifications

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