Site Activation Partner
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Job Description
Site Activation Partner overseeing start-up phase of clinical trials at Parexel. Building relationships with investigators and ensuring compliance with regulatory requirements.
Responsibilities:
- Act as direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Support on request country specific feasibility and/or site pre-qualification and qualification activities.
- Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ).
- Develop strategy to configure, distribute, collect, and review high quality country and/or site specific documents.
- Customize, review, and negotiate country/site specific Informed Consent Forms (ICF).
- Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
Requirements:
- Strong local ethics committee/ Regulatory experience
- Strong problem-solving skills
- Excellent presentation skills
- Client focused approach to work
- Strong ability to prioritize multiple tasks and achieve project timelines
- Substantial startup experience or equivalent experience in clinical research
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Benefits:
- Health insurance
- Professional development opportunities
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