Senior Clinical Research Associate - FSP

Some specifics about this role:

• Primarily responsible for initiating, organizing and managing the assigned trials, ensuring the
• trials can be conducted as per timeline requirement
• On-site monitoring and site management for global studies
• Ensure clinical trials are conducted in compliance with local, national and regional protocols
• and ICH-GCP
• Drives performance at site by proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
• Additional responsibilities for Senior CRAs:
• Contributes to selection of potential investigators
• May be accountable for study start-up and regulatory tasks, including from collection to tracking of documents for Site Qualifications visits, submission of proper documents to EC/IRB and Regulatory Authorities for start-up and throughout the study
• Ensure sites are inspection-ready at all times by ensuring site staff have completed and documented all required trainings, as well as train/support/advise PI and site staff on study-related matters, including RbQM principles.

What we look for in:

Requirements vary, depending on the sponsor you will be working for, but generally you’ll need to be an experienced Clinical Research Associate already.

We look for people who are not only skilled at the technical aspects of site monitoring, but can also contribute to broader study design and management.

And for every CRA role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this role:

• Bachelor degree or above, major in pharmacy or health science related background.
• Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management
• At least 1-2 years of experience in the role of CRA including on-site monitoring. Candidates with longer tenure can be considered for Senior CRA.
• Excellent command of English (both written and spoken).
• Good negotiation, collaboration and interpersonal skills