HireTalent - Staffing & Recruiting Firm · 16 hours ago
Senior Clinical Data Coordinator - C
Pleasanton, CA
Full-time
Onsite
Senior LevelHireTalent is a staffing and recruiting firm currently seeking a Senior Clinical Data Coordinator to support their Investigator Sponsored Studies team. The role involves processing clinical documentation, ensuring compliance with FDA regulations, and providing administrative support to enhance the efficiency of the ISS process.
DeliveryHuman ResourcesStaffing Agency
Responsibilities
Processing incoming forms accurately and according to departmental processes. This includes the accurate and timely entry of forms into a database, the quality review and verification of forms already entered, the identification and correction of errors and the organization of clinical documentation (forms, correspondence and other supporting clinical documentation)
Analyzing problems, characterize issues and determine appropriate solutions
Providing administrative support for ISS as requested. This could include generating mail merges, faxing, copying, filing, mailings, etc
Resolving and/or facilitating resolution of problems including identifying causes of problems to prevent reoccurrence of problems
Supporting Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complying with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Clinical Data Coordinator experience or experience in a comparable or closely related clinical research environment, including direct familiarity with data management processes
Strong skills with MS Office applications, specifically Excel, Word, and PowerPoint are required
Advanced organizational skills, attentiveness to detail, ability to work under limited supervision, and ability to handle multiple projects simultaneously
Ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential
Must have comprehensive interpersonal skills, including the ability to listen, resolve relatively complex problems, and deal with unresolved issues, delays and unexpected events, while effectively communicating and maintaining rapport with field clinical engineers and study coordinators
Must be able to use discretion and handle sensitive/confidential information appropriately
Occasional overtime is a requirement of this position
Preferred
Bachelor's degree (preferred) or an equivalent combination of education and work experience required
Experience with FDA, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) regulations as they apply to Clinical Data Management and to the clinical trial process
Experience using Concur for payments is preferred
Ability to work in a highly matrixed and geographically diverse business environment
Company
HireTalent - Staffing & Recruiting Firm
HireTalent is a certified Minority Business Enterprise (MBE) workforce solutions firm, specializing in securing the best talent fits in Executive/Retained Search, Direct Hire Placements, MSP, SOW, and nationwide hiring program management and support.
Founded in 1997
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashish Kaushal
CEO / Founder
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