SunnyvaleFull TimeOperations
Remotely
gcpclinical researchregulatory compliancebudget managementctmstrial master fileiso 14155
Job Description
📋 Description
- Coordinate ordering, shipping, labeling and tracking of study supplies
- Maintain trial master file and CTMS for regulatory and protocol compliance
- Support study budgets, payments to sites and vendors
- Prepare and ship site and patient binders as needed
- Create study materials and collaborate with CSM/CRA for study execution
- Schedule and plan meetings, distribute agendas and minutes
🎯 Requirements
- Strong communication, organization and attention to detail
- Ability to manage multiple priorities
- Experience in medical device clinical trials and regulatory support
- Proficient in MS Office, Adobe, video/web conferencing
- Knowledge of GCP (21 CFR) and ISO 14155; 21 CFR Part 812
- 2-4 years clinical research experience; bachelor’s degree preferred
🎁 Benefits
- Market-competitive compensation with base pay and incentives
- Benefits and equity; compensation ranges depend on location/experience
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