Associate Analyst, Clinical Operations

$62,400 - $79,040/Yr

Talentburst - Irvine, CA

Part-time - Entry Level

Remote - Irvine, CA

Administrative and Support Services

About the position

The Associate Analyst in Clinical Operations plays a crucial role in supporting clinical research initiatives within the Critical Care business unit. This position involves managing clinical study device activities, ensuring compliance with regulations, and collaborating with various internal stakeholders to enhance the efficiency and accuracy of clinical processes. The role requires strong communication skills and attention to detail, as well as the ability to work in a fast-paced environment.

Responsibilities

• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices.
• Partner with internal stakeholders to improve device processes.
• Verify inventory in JDE and process device shipments to clinical sites.
• Confirm receipt of products with clinical sites and obtain signed packing slips.
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists.
• Develop timeline assessments in collaboration with clinical stakeholders.
• Ensure documentation is archived appropriately within the record retention facility.
• Review and ensure accuracy of clinical study files and enter them into tracking systems.
• Identify and implement process improvement solutions to optimize trial workflows.
• Support clinical research laboratory operations as needed.
• Perform other incidental duties as assigned.

Requirements

• Bachelor's Degree
• 0-2 years of experience
• Good computer skills including MS Office Suite and Adobe
• Good written and verbal communication skills
• Ability to work in a fast-paced environment
• Strict attention to detail

Nice-to-haves

• Clinical research coordination
• Clinical study management
• Study document review (e.g., ICF and CRF)
• Experience with EDC, CTMS, Veeva (TMF)
• GCP training
• Experience with medical device studies

Benefits

• Competitive hourly wage of $30-$38
• Part-time schedule with 20 hours per week
• On-site work environment