Clinical Operations Jobs

Real Staffing is hiring a Clinical Operations Analyst for a large medical device client local to Irvine, CA

This will be a W2- contract opportunity with competitive pay.

Position Summary

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.)
• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
• Analyze clinical output of moderately complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management
• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; assist in the determination of root cause and recommend and implement corrective actions
• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables.
• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

Education, Experience, and Other Requirements:

• 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
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Good problem-solving, organizational, analytical and critical thinking skills
• Strict attention to detail
• Excellent written and verbal communication skills and interpersonal relationship skills
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Solid understanding and knowledge of principles, theories, and concepts relevant to clinical trial management
• Bachelor's Degree in related field AND * 3 years of previous hands-on clinical research experience
• Solid knowledge of human anatomy and physiology
• Good computer skills in usage of MS Office Suite including MS Project and excellent Excel skills required