Clinical Operations Spec 1 - Onsite (Must at least 2 yrs in clinical research exp)

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

Job summary

MillenniumSoft Inc in Irvine, CA seeks a Specialist 1, Clinical Operations for a 12-month on-site assignment. Hours are Mon-Fri, 8am-5pm; pay rate is $35-$40/hr and will be determined at offer. The role supports device workflow, inventory control and study documentation across clinical trials.

You will coordinate study inventory, ensure TMF filing, and collaborate with clinical teams to meet milestones. At least 2 years in clinical research is required.

Qualifications

• Minimum 2 years of clinical research experience required.
• Experience developing and implementing device-related trial processes.
• Strong documentation and regulatory compliance focus.

Responsibilities

• Identify, develop and implement moderately complex process improvements for trial workflows.
• Develop and manage device processes for clinical trials with internal stakeholders.
• Coordinate procurement and shipment of study devices to sites on schedule.
• Ensure TMF documentation is complete and archived properly.
• Monitor inventory levels, forecast needs, and support milestone planning.
• Generate reports for Sunshine Act compliance and study invoicing.

Skills

Clinical research

Process improvement

Device processes

Inventory management

Documentation

Education

Associate's degree

Bachelor's degree

Job description

Job Location

17200 Laguna Canyon Road, Irvine, California, United States of America, 92618

Duration

12 Months

Job Title

Spec 1, Clinical Operations

Number of Positions

1

Job Description -

Specialist 1, Clinical Operations

On Site Role

Hours: Mon-Fri, 8am - 5pm

Pay Rate - $35 - $40/hr (pay rate will be determined at time of offer)

Must have at least 2 years in clinical research experience

• 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

Preferred Experience/qualifications

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