Job Description

Clinical Research Associate (CRA) Job Description

The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP), and applicable Project Management Plan (PMP) and local regulatory requirements.

Job Responsibilities

• Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
• Evaluate potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites.
• Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
• Assist PM in start-up meetings. Participate in investigator meetings as necessary.
• 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.
• Act as the key contact person for 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.
• Prepare monitoring reports according to the SOP.
• Assist the investigator for auditing/inspection of the project.
• Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.

Education and Experience

• A 4-year BS (Bachelor of Science) degree or equivalent experience. Advanced degree is a plus.

Skills and Competencies

• At least 2-year experience in a clinical research environment.
• Good command of written and spoken English or another second language.
• Good organization and communication skills.
• High attention to detail and accuracy.
• Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs.

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.