Clinical Research Associate - Hafei

Responsibilities:

• Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
• Prepare and manage the clinical trial agreements with investigators/sites.
• Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
• Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
• Monitor and report the project status at the sites in a timely manner.
• Key contact person for the communication between the sites and study team.
• Prepare, arrange and conduct the training of site personnel.
• Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.

Qualifications:

• 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.
• At least 1 year experience in clinical research environment.
• High attention to detail and accuracyGood organization and communication skills.
• Good command of written and spoken in English or other second language.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.