Select Source International · 2 days ago
Clinical Operations Associate
Pleasanton, CA, US
Full-time
Onsite
New Grad, Entry LevelSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions. The Senior Clinical Data Coordinator/Investigator Sponsored Studies Associate will provide essential support for Investigator Sponsored Studies, ensuring the quality and efficiency of clinical documentation and processes.
ConsultingFinancial ServicesInformation Technology
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
Medical/pharma experience required: Yes—needed for understanding terminology and taking meaningful minutes
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
Select Source International
Select Source International (SSI) is an award-winning global leader in Consulting and Staff Augmentation, helping businesses thrive across IT, Healthcare, Finance & Accounting, Human Resources, Engineering, Energy & Utilities, Manufacturing, Administrative, Operations & Logistics, and more.
Founded in 1999
501-1000 employees
H1B Sponsorship
Select Source International has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (3)
2022 (2)
2020 (4)
Funding
Current Stage
Late StageCompany data provided by crunchbase