Clinical Research Spec 1 - Onsite (Req 2 Yrs of Exp in Clinical Research) - Urgent Need

Location: Irvine, CA • Duration: 12 months • Schedule: Mon–Fri, 8 am–5 pm • Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, or CPT only)

About the role

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 internal key stakeholders—such as clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups—to develop and lead the execution of the device process and drive continuous improvement in efficiency and accuracy of processes and procedures.

Responsibilities

• 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 product through to final disposition; ensure required documentation is 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 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 is 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 across multiple clinical research trials.
• Support clinical research laboratory operations as needed.
• Perform other incidental duties to support clinical study operations.

Requirements

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

Pay

$35–$40/hr (pay rate determined at time of offer).