Key Role Summary
As a Clinical Research Associate II, you will play a vital part in ensuring the smooth execution of clinical trials. Your primary responsibility will be to monitor and coordinate various aspects of the clinical monitoring and site management process.
Responsibilities
* Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
* Lead procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).
* Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
* Ensure audit readiness.
Requirements
* Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
* Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials may be considered.
* Valid driver's license where applicable.
Desirable Skills
* Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents.
* Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
* Ability to maintain customer focus through the utilization of good listening skills and attention to detail.
* Good organizational and time management skills.
Benefits
* Comprehensive benefits package.
* Flexible work arrangements.
* Generous leave policies.
* Opportunities for professional development and growth.
Thermo Fisher Scientific Australia is an equal opportunity employer committed to diversity and inclusion.