Clinical Trial Associate II
New
O
OraOphthalmic Clinical Research
Remote - USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 1-year experience in clinical trials associate
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor's degree or equivalent years of relevant experience.
- Minimum 1 year of experience as a Clinical Trial Associate.
- Strong knowledge of GCP (Good Clinical Practice) and ICH regulations.
- Experience maintaining electronic trial master files.
- Ability to work effectively in a semi-virtual, cross-functional team.
- Strong analytical and problem-solving skills with attention to detail.
- Excellent verbal and written communication skills.
- Exceptional organizational and time management skills for managing multiple trials.
- Ability to remotely problem-solve with clinical site staff.
- Ophthalmic clinical experience is strongly preferred.
Responsibilities
- Ensure study documentation, communication, training and data collection are aligned with protocol adherence and applicable regulations.
- Develop study-related documents including informed consent, source documents, and study logs.
- Manage clinical trial site activities from startup through conduct and close-out.
- Collect and review regulatory documents such as 1572s and financial disclosure forms.
- Create regulatory packages for IRB/IEC and maintain clinical study tracking systems.
- Set up and maintain the electronic Trial Master File (eTMF) and project file-sharing platforms.
- Support project management by preparing meeting minutes, newsletters, and study reports.
- Assist with audit preparations for Sponsors and regulatory bodies.
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