[Hiring] Clinical Research Associate II/III @Novotech Global

Role Description

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

• Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely, and productive project delivery as per study requirements and timelines.
• In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
• Understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials in collaboration with the Regulatory Start-up (RSU) Team.
• Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
• Monitor investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study, including all monitoring visit types across all phases of a clinical trial.

Qualifications

• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
• Good time management skills and attention to detail.
• Able to work well in a team and be computer literate.
• Preferably at least 2 years of Clinical Research Associate experience in the research or pharmaceutical industry.

Benefits

• Flexible working options.
• Paid parental leave for both parents.
• Flexible leave entitlements.
• Wellness programs.
• Ongoing development programs.

Company Description

Novotech is a global full-service clinical Contract Research Organization (CRO). We are a recognized leader in clinical research and scientific advisory services, committed to fostering an environment that reflects the life-changing work we do.

• Named Employer of Choice, Great Place to Work, and Employer of Choice for Gender Equality (EOCGE).
• Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
• Offers mentorship opportunities, professional development programs, and a dynamic community.
• Empowers team members to create an effective work-life balance through programs like NovoLife.
• Culture that fosters partnership and collaboration, where every voice is heard and valued.