Generis Tek Inc · 19 hours ago
Senior Clinical Data Coordinator - C
Pleasanton, CA
Full-time
Onsite
Senior Level
$41/hr - $41/hrGeneris Tek Inc is a boutique IT/professional staffing company based in Chicago land. They are seeking a Senior Clinical Data Coordinator to provide support for Investigator Sponsored Studies, ensuring quality documentation and compliance with FDA regulations.
Information Technology & Services
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
Generis Tek Inc
Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.
Founded in 2015
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase