Clinical Trial Coordinator (Part-time)

Description

• 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.

• Verify inventory in JDE and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and Warehouse. Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists

• Develop timeline assessment (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.

• Ensure documentation are archived appropriately within record retention facility (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

• 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.)

• Support clinical research laboratory operations as needed

Essential Skills

• Bachelor's Degree
• 1-2 years of experience in clinical study management
• Good computer skills including MS Office Suite, Adobe, and the ability to operate general office machinery
• Good written and verbal communication skills
• Strong interpersonal relationship skills
• Ability to work in a fast-paced environment
• Strict attention to detail

Additional Skills & Qualifications

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

• Good written and verbal communication skills and interpersonal relationship skills

• Ability to work in a fast paced environment

• Strict attention to detail

Part time work schedule - 4 days on site/week (8-12am) with flexibility to WFH on Fridays OR candidates can choose to work 2.5 full days each week (e.g. Mon, Weds + Thurs only) instead of splitting the 20 hours across 5 days if that is their preference