Clinical Research Specialist 1 - Req 2 Yrs Exp in Clinical Research (Onsite)

MillenniumSoft Inc; Irvine (CA); In loco; USD 48.000 - 55.000; Tempo pieno

Descrizione del lavoro

MillenniumSoft Inc. is seeking a Clinical Research Specialist 1 in Irvine, CA. This contract position (12 months) is on the 1st shift, 40 hours per week, with a $35–$40/hr W2 arrangement.

The role focuses on managing device-related processes for clinical trials, coordinating inventory, TMF documentation, and ensuring regulatory compliance. Ideal candidates have 2+ years of clinical research experience and an Associate’s or Bachelor’s degree in a related field.

Competenze

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

Mansioni

• Identify, develop, and implement moderately complex process development and improvement solutions to optimize trial workflows.
• Develop and execute device-related processes for clinical trials, coordinating with study teams, Manufacturing, Finance, Supply Chain, Quality and Compliance.
• Coordinate procurement and shipment of study inventory to clinical sites within timelines.
• Confirm receipt of study product at sites and track to final disposition, filing TMF documentation.
• Monitor inventory levels and assist with forecasting to meet study milestones.
• Produce transparency reports for Sunshine Act compliance as needed.
• Track and coordinate invoice processing and payments, reporting on outstanding invoices.
• Archive documentation in record retention facilities (e.g., Iron Mountain, clinicaltrial.gov).
• Review accuracy of clinical study files, enter into tracking systems, and scan/archive files.
• Support clinical research laboratory operations as needed.
• Perform other duties to support study operations.

Conoscenze

Clinical research

Process development

Process improvement

Formazione

Associate's degree

Bachelor's degree

Descrizione del lavoro

Position : Clinical Research Specialist 1

Location : Irvine, CA

Duration : 12 Months

Shift : 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)

$35-40/hr

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.
• 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