Clinical Research Specialist - Patient-Facing Entry-Level

MillenniumSoft Inc; Irvine (CA); In loco; USD 34.000 - 49.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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).

Mansioni

• 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

Conoscenze

Patient-facing experience

Clinical research

Regulatory compliance

Documentation

Formazione

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

Descrizione del lavoro

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.