We are seeking an experienced Clinical Research Associate (CRA) to support monitoring and site management activities across multiple studies. The role involves close collaboration with study teams, sites, and cross-functional stakeholders, with a strong commitment to patient safety, data integrity, and product quality.
Key Responsibilities
- Conduct on-site and remote monitoring activities , including visit preparation, follow-up, site contact, and report writing.
- Support site start-up activities , including EC/CA submissions, contract negotiation, and essential document collection.
- Attend study meetings and collaborate with cross-functional teams and sites throughout all study phases.
- Provide support in audit preparation and responses .
- Schedule and conduct monitoring visits according to the study monitoring plan.
- Review informed consents, regulatory files, and site st...