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Role Overview:
- Support clinical studies from start-up to closeout in a regulated environment.
- Collaborate with cross-functional teams across R&D, Regulatory, Safety, and Quality.
Key Responsibilities:
- Manage study start-up activities including protocol development, IRB submissions, and site coordination.
- Ensure compliance with FDA regulations, GCP, and internal SOPs throughout trials.
- Track study financials and provide administrative support for Trial Master Files.
Requirements:
- Bachelor's degree in life science or related field with 3+ years of clinical trial experience.
- Strong knowledge of GCP and FDA regulatory requirements, with excellent organizational skills.
- Proficiency in Microsoft Office and ability to work independently in a remote setting.
Benefits:
- Competitive salary with incentive programs and comprehensive insurance coverage.
- Fully remote work within the US with professional growth opportunities.
Jobgether
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.