About the role

PSI CRO AG is seeking an experienced Clinical Research Associate II to join our growing team in Sydney, NSW. As a Clinical Research Associate II, you will be responsible for managing and coordinating clinical research activities across multiple clinical trial sites. This is a full-time position based in our Sydney office.

What you'll be doing

Monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements

Reviewing and verifying source data and case report forms to ensure data integrity and accuracy

Identifying and resolving issues related to patient enrolment, data collection, and study conduct

Providing training and support to site staff on study procedures and documentation requirements

Collaborating with the project team to develop and implement strategies to improve study performance and address any challenges

Preparing and maintaining comprehensive monitoring reports and other documentation

Assisting with the preparation of study-related regulatory submissions and audit responses

What we're looking for

Bachelor's degree in a life science or a related field

At least 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical, biotechnology, or contract research industry

Strong understanding of GCP guidelines, ICH regulations, and applicable national and international regulatory requirements

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams

Proficient in data management, analysis, and reporting

Attention to detail and the ability to work independently and prioritise tasks effectively

Willingness to travel to clinical trial sites as needed

What we offer

At PSI CRO AG, we are committed to providing our employees with a rewarding and fulfilling work experience. As a Clinical Research Associate II, you will have the opportunity to work with a talented and dedicated team, contribute to the development of innovative therapies, and advance your career in the dynamic field of clinical research. We offer competitive remuneration, opportunities for professional development, and a range of employee benefits, including 5 additional wellness leave and team get-together on quarterly basis.

About us

PSI CRO AG is a leading global CRO that provides a full range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. With a focus on quality, innovation, and client satisfaction, we have been delivering successful clinical trials for over 30 years. Our team of experienced professionals is dedicated to advancing the development of life-changing therapies and improving the health and well-being of people around the world.

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