Clinical Study Coordinator

Position Title: Clinical Study Coordinator

Work Location: Irvine, CA 92614

Assignment Duration: 12 Months

Work Arrangement: Onsite

Position Summary:

As the Clinical Device Management Associate Analyst, you will support device processes associated with clinical trials. You will also ensure compliance with regulations and manage the lifecycle of device inventory and accountability to support clinical trials.

Key Responsibilities:

• Partner with stakeholders to manage inventory and device accountability for sites
• Ensure clinical sites are sufficiently set up and stocked with trial supplies and track their lifecycle in related system/tool under general supervision
• Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
• Retrieve, review, and ensure GDP accuracy and completeness of clinical study documents and performing quality checks with increased complexity
• Regularly communicate with site and field team to resolve basic queries
• Investigate and analyze discrepancies between site and JDE data on device accountability in collaboration with stakeholders (e.g., Finance, Customer Service, Clinical IT)
• Provide training on device accountability process within electronic database (e.g., Salesforce) for cross functional team members (e.g., clinical specialist and field monitors)
• Identify, develop, recommend, and implement basic process development and improvement solutions to trial workflow timelines (e.g., device accountability data)
• Partner with Quality to resolve device related issues
• Compile and analyze data to support regulatory submissions for the regulatory bodies (e.g., FDA)
• Other incidental duties

Qualification & Experience:

• Bachelor’s Degree in related field with minimum 1 year of previous related clinical trial support or Clinical operations experience
• Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System) - Preferred
• Possess strict attention to detail
• Ability to work 5 days on-site
• Strong problem-solving, organizational, analytical and critical thinking skills
• Strong written and verbal communication skills
• Strong interpersonal relationship skills
• Good computer skills in usage of MS Office Suite including Excel, JDE, electronic database (e.g., Salesforce)
• Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
• Ability to manage confidential information with discretion
• Ability to manage competing priorities in a fast-paced environment
• Good understanding and knowledge of investigational device accountability
• Good knowledge of regulatory requirements and documents (e.g., Code of Federal Regulations, Good Clinical Practices, Good Documentation Practices)
• Good understanding and knowledge of clinical trial master files (TMFs)
• Ability to interact professionally with all organizational levels and site personnel
• Must be able to work in a team environment, including immediate supervisor and other team members
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control