Select Source International · 6 hours ago
Clinical Study Support Coordinator
Pleasanton, CA
Contract
Onsite
New Grad, Entry Level
$43/hr - $48/hrSelect Source International is focused on supporting Medical Device Medical Affairs, and they are seeking a Clinical Study Support Coordinator to manage Investigator Sponsored Study documentation and processes. The role involves ensuring compliance with regulatory requirements and internal procedures while providing administrative support for clinical studies.
ConsultingFinancial ServicesInformation Technology
Responsibilities
Process incoming ISS forms accurately and in accordance with departmental procedures
Perform timely and accurate data entry into databases and conduct quality review and verification of submitted forms
Identify, correct, and prevent documentation errors; organize clinical documentation, correspondence, and supporting records
Analyze issues, characterize problems, and recommend appropriate solutions to improve process efficiency and quality
Provide administrative support for ISS activities, including mail merges, faxing, copying, filing, and mailings
Proactively identify root causes of issues and facilitate resolution to prevent recurrence
Communicate with customers, study coordinators, and field clinical engineers to clarify missing or inconsistent data
Support company initiatives related to QMS, Environmental Management Systems (EMS), and other regulatory requirements
Ensure compliance with FDA regulations, company policies, and operating procedures
Collaborate effectively with internal teams, contractors, vendors, and external stakeholders
Participate in cross-training across all ISS processes supported by Medical Device Medical Affairs
Qualification
Required
Experience as a Clinical Data Coordinator or in a comparable clinical research or data management environment
Strong proficiency in MS Office applications, particularly Excel, Word, and PowerPoint
Demonstrated ability to work independently with limited supervision while managing multiple priorities
High level of organizational skill and attention to detail
Ability to understand and comply with FDA regulations, company procedures, and regulatory standards
Strong interpersonal and communication skills, including the ability to resolve moderately complex issues
Ability to handle sensitive and confidential information with discretion
Willingness to work occasional overtime as required
High school diploma required; Bachelor's degree preferred
Medical or pharmaceutical industry experience required to understand terminology and document meaningful discussions
Clinical data management or clinical research coordination experience
Strong writing and documentation skills
Advanced Excel skills
Ability to enhance and improve existing tools and processes
Familiarity with FDA-regulated environments
Experience working with systems such as: Excel, Word, Outlook, MS Teams, Adobe PDF, DocuSign, Chrome, Salesforce (contracts), Concur, Ariba, OwnIt, I Envision, Blackboard
Preferred
Bachelor's degree or equivalent combination of education and experience
Experience with FDA, GMP, and GCP regulations
Prior experience using Concur for payments
Experience working in a highly matrixed and geographically diverse environment
Background supporting medical device or pharmaceutical studies
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