Clinical Research Associate – FSP

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Assists in the identification of potential investigators.

• In certain countries, CRAs are responsible for study initiation and regulatory upkeep as necessary.

• Provides training, support, and guidance to Investigators and site personnel regarding study-related issues.

• Maintains site readiness for inspections at all times.

• Actively engages in Local Study Team (LST) meetings.

• Promotes performance improvements at the sites.

• Updates the CTMS and other systems with data from study sites according to established timelines.

• Conducts monitoring visits, both remote and in-person.

• Ensures timely resolution of data queries.

• Assists in or participates in regular quality control checks conducted by LSAD or their delegate.

• Ensures adherence to the client’s Code of Ethics, as well as company policies and procedures.

⛳️ Requirements

• Bachelor’s degree in a relevant field, preferably in life sciences, or an equivalent qualification.

• Strong knowledge of international regulations such as ICH-GCP, along with basic understanding of GMP/GDP.

• Familiarity with applicable local regulations.

• Good medical knowledge with the capacity to learn about the client's Therapeutic Areas.

• Basic comprehension of the drug development process.

• Solid understanding of Clinical Study Management, including monitoring, study drug handling, and data management.

• Exceptional attention to detail.

• Strong written and verbal communication abilities.

• Effective collaboration and interpersonal skills.

• Proficient negotiation skills.

• Willingness to travel nationally and internationally as required.

🏝️ Benefits

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.