Clinical Research Associate
Deliver high-quality site monitoring activities and contribute to the timely delivery of clinical projects.
About the Role
We are seeking a skilled Clinical Research Associate to ensure adherence to quality standards and timelines. The successful candidate will have a strong understanding of ICH GCP and applicable clinical trial regulations.
Key Responsibilities
* Site Monitoring: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
* Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
* Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
* Continuous Skill Development: Regularly enhance both technical and soft skills to improve performance and project outcomes.
* Work Relations: Report to the Manager of Clinical Operations and collaborate with site monitoring teams, site personnel, HR, site leads, and administrative staff.
Value Added
Your dedication to quality and timelines will be crucial for the efficient delivery of projects and overall success.
Key Success Factors
* Timely and high-quality execution of site monitoring activities.
* Punctual report generation and submission to stakeholders.
Essential Skills and Experience
* Education: Bachelor's or Master's degree in a scientific discipline.
* Experience: 1-4 years in site monitoring within clinical research.
* Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent communication skills; ability to multitask and work under demanding timelines.
What We Offer
A dynamic and supportive work environment that fosters professional growth and development.