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

Job Title -Spec 1 Clinical Operations

Number of Positions -1

Job Location -17200 Laguna Canyon Road Irvine California United States of America 92618

Duration: 12 Months

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

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 )
• 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:

• Associates/Bachelors degree in a related field