Job Title: Clinical Trials/Research Analyst (EDC)
Pay Rate: $45 to $50/Hr
Duration: 12 Months (may get further extension or conversion based on performance)
Location: Irvine, CA
Shift - 8 AM to 5 PM PST
Our Client is a Global medical device Manufacturer.
We are looking for a Clinical Trials/Research Analyst (EDC)
As the Clinical Trials/Research Analyst for our THV Core Labs team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all THV global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to data management teams to ultimately provide unbiased study results
• Analyze the 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 them 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.)
• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff
Education and Experience:
• Bachelor's Degree in STEM or healthcare
• 3+ years of hands-on clinical research experience
• Clinical trial/research background with medical devices. If in a cardiovascular or clinical imaging setting, it's a huge plus! (Must have)
• Track record of supporting 3 or more ongoing trials at one time.
• Recent work experience with EDC Rave. (Must have)
• Highly skilled in Excel & SharePoint. (Must have)
• Experienced with interpreting clinical data. (Must have)
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with 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's 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
Soft skills:
• Must be a team player, this group is highly collaborative.
• Highly organized.
• Proven communicator.
Location: Irvine, CA
Posted: Oct. 15, 2024, 7:39 a.m.
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