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Site Activation Partner I
Location
Turkey
Posted
52 days ago
Salary
0
Seniority
Mid Level
Job Description
Site Activation Partner I
Parexel
• Initiate and coordinate activities during start up towards the compilation of a high quality Investigator Initiation Package (IIP) • Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities • Support the compilation of the Central Investigator Review Board package and submissions to approval of the study • Coordinate the timely communication, documentation and responses between client and central ethics committee • Support investigators sites with local IRB workflow from preparation, submission through approval
Job Requirements
- Minimum 2 years relevant experience in clinical site management
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
- Understand basic medical terminology, GCP requirements and proficient in computer operations
- Must be fluent in local language and in English
- Good technical skills and ability to learn and use multiple systems
Benefits
- Competitive salary
- Health insurance
- Paid time off
- Professional development opportunities
- Flexible working arrangements
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