Clinical Operations Analyst at Roth Staffing Companies in Irvine, California

Job Description:

Clinical Operations Analyst


Duration - 12+ Months, high probability to extend/convert


Location - Hybrid in Irvine, CA (1 day remote)


Pay - $40 - $45 an hour


Summary:


Key Responsibilities:


• 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 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



• 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 department to communicate risk and impact to study 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


Qualifications & Skills:


• Bachelor's Degree in STEM or healthcare


• 3+ years of hands-on clinical research experience


• Clinical trial/research background with medical devices (cardiovascular or clinical imaging setting highly preferred)


• Experience supporting 3+ ongoing trials at one time


• Experience with EDC Rave, ERP (JDE) and CTMS (Clinical Trial Management System) & highly skilled in MS Office Suite (Excel & SharePoint) & Adobe


• Experienced with interpreting clinical data.


• Must be a team player, this group is highly collaborative.


• Highly organized, proven communicator, Ability to work in a fast paced environment


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific