Remote iCRA - Initiation Clinical Research Associate chez PAREXEL

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Responsibilities:

• Manage and direct the strategy for study start-up, pre-Site Initiation Visit (SIV) tasks, and study activation.
• Act as the direct point of contact with assigned sites.
• Develop relationships with investigators and site staff.
• Manage country-specific feasibility activities and/or site qualification. Handle essential regulatory documents and informed consent forms.
• Prepare and submit applications to IRB/IEC and MoH/RA.
• Develop and review plans for regulatory approval, site activation, and patient recruitment.
• Resolve issues and escalate site-related matters.
• Conduct on-site and remote visits.
• Ensure compliance with ICH-GCP and applicable regulations.

Key Skills:

• Problem-solving.
• Independent work.
• Presentation skills.
• Customer-focused approach.
• Multi-tasking.
• Strong interpersonal and communication skills.
• Attention to detail.

Requirements:

• University degree in biological sciences, pharmacy, or health-related discipline (preferred).
• Relevant previous work experience (preferred).
• Good English skills.