Site Activation Partner I
Parexel
full-time
Posted on:
Location Type: Remote
Location: Turkey
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Tech Stack
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical site managementregulatory document preparationinvestigator initiation package (IIP)IRB approval processclinical trial methodologiesICH/GCPFDA regulationsmedical terminologyGCP requirementscomputer operations
Soft Skills
coordinationcommunicationdocumentationtimelinesssupportorganizational skillsinterpersonal skillsproblem-solvingadaptabilityattention to detail