Clinical Operations Analyst

2 weeks ago

Irvine, United States CYNET SYSTEMS Full time
Job Description:

Pay Range $40.31hr - $44.31hr

Responsibilities:
  • Analyze clinical output of moderately complex studies and provide a 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.
  • 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.).
  • 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.
  • Provide guidance and represent the department to communicate risk and impact to study the core team's key milestones and deliverables.
  • Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff.
Additional Skills:
  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery.
  • Experience with an ERP software, JDE, and CTMS (Clinical Trial Management System) preferred.
  • Good written and verbal communication skills and interpersonal relationship skills.
  • Ability to work in a fast-paced environment.
  • Substantial knowledge and understanding of client policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation.
  • Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
  • Good problem-solving skills.
  • Ability to manage confidential information with discretion.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Must be able to work in a team environment under minimal supervision.
  • No instructions are needed on routine work, and general instructions are given only on new lines of work or special assignments.
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
Education and Experience:
  • Bachelor's Degree in STEM or healthcare.
  • 3+ years of hands-on clinical research experience.

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