Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Clinical Research Associate I / II - FSP
Job ID R0000042989 Kowloon, Kowloon City, Hong Kong SARFSP CRA opening (Global Pharmaceutical Company FSP Team) for CRA I or II level.
This role requires to go to Client's office 1-2 days a week.
Key Accountabilities:
Study Team Supporting
Drive study performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
Contribute to the selection of potential sites and investigators. Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies, drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data.
Ensure accurate and timely reporting of Serious Adverse Events.
Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centers as per required timelines.
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.
Adherence to AstraZeneca’s Code of Conduct and company policies and procedures.
Compliance with Parexel standards
Comply with required training curriculum.
Complete timesheets accurately as required.
Submit expense reports as required.
Update CV as required.
Maintain a working knowledge of and comply with Parexel processes, ICHGCPs and other applicable requirements.
Skills:
Understanding of the clinical dataflow.
Good knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations.
Good computer skills in Microsoft and other software.
Fluent in both oral and written English
Proficient written and verbal communication skills, collaboration and interpersonal skills.
Knowledge and Experience:
Minimum 2-year experience as CRA, performed all tasks for a CRA position
Read, write, and speak fluent English; fluent in host country language required.
Education:
Bachelor’s degree in biological science or healthcare-related field., or equivalent
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs