Site Monitoring Specialist
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Clinical research involves conducting studies to ensure the quality and safety of new treatments and medications. As a Site Monitoring Specialist, your role will be crucial in supporting the timely and high-quality delivery of site monitoring activities in line with our Site Monitoring Plan (SMP).
Primary Purpose:
We are seeking skilled professionals to work closely with our team to deliver top-notch clinical research services. Your primary responsibilities will include managing sites according to our Master Plan and relevant regulations, identifying new potential sites across various therapeutic areas, and improving technical and soft skills to enhance performance.
Key Responsibilities:
1. Deliver on the Site Monitoring Plan: Understand the Master Plan, study protocol, and project plan to ensure adherence to timelines and quality standards.
2. Site Management Compliance: Manage sites in accordance with regulatory requirements and minimize audit observations.
3. Site Identification: Identify new potential sites across various therapeutic areas to expand our clinical network.
4. Continuous Skill Development: Regularly improve technical and soft skills to enhance performance and project outcomes.
Work Relations:
1. Report to the Manager of Clinical Operations regarding project matters.
2. Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Value Added:
Your commitment to delivering high-quality site monitoring activities is essential for the efficient delivery of our projects and overall success.
Key Success Factors:
1. Timely and high-quality site monitoring activities.
2. Prompt report generation and submission to stakeholders.
3. Bachelor's or Master's degree in a scientific discipline.
4. 1-4 years of experience in site monitoring within clinical research.
5. Strong understanding of ICH GCP and clinical trial regulations; excellent communication skills; ability to multitask under demanding timelines.