Senior Clinical Research Specialist
New
Based in the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least 6 years
Requirements
- Bachelor’s degree in a scientific discipline, nursing, or related field.
- At least 6 years of experience in clinical research or clinical trial operations.
- Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Familiarity with US clinical research regulations.
- Experience in clinical trial coordination, preferably in medical device or regulated environments.
- Strong organizational and multitasking skills.
- Strong written and verbal communication skills.
- Proficiency with clinical systems and standard office tools (spreadsheets, databases, document management systems).
- High attention to detail and analytical mindset.
Responsibilities
- Manage and maintain Trial Master Files (TMF) to ensure documentation accuracy and inspection readiness.
- Track and monitor study progress across multiple systems, including essential documents and subject visit milestones.
- Coordinate regulatory submissions and support IRB/EC processes.
- Provide operational and administrative support, including meeting coordination and cross-functional communication.
- Support clinical site interactions by assisting with enrollment tracking and issue resolution.
- Contribute to study start-up, execution, and close-out activities.
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