Position

As a Clinical Trials Associate, APAC in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of Phase I-III insourced global clinical studies within the oncology portfolio. Operating in a dynamic and collaborative environment, you will provide essential support for the execution of clinical trials, contributing to the development of groundbreaking therapies with the potential to transform patient lives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

This position requires bilingual fluency in English and Mandarin/Cantonese/Japanese/Korean. Candidates without this qualification will not be considered due to the nature of interacting with locally based trial sites in Asia.

About You

You are passionate about playing a key role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. You have strong communication skills and a passion for advancing care to patients.

What You’ll Do

• Assist in the preparation and maintenance of essential study documents, including study protocols, informed consent forms, case report forms (CRFs), and other trial-related materials
• Collaborate with cross-functional teams to ensure accurate and timely completion of study start-up activities, such as site selection, feasibility assessments, and ethics committee submissions
• Support the organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings
• Coordinate and track the distribution, collection, and reconciliation of trial supplies, investigational products, and study related materials
• Assist in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems
• In collaboration with TMF Operations team, maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs
• Facilitate effective communication among study team members, investigators, and study site personnel through regular correspondence and timely dissemination of study-related information
• Support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones
• In collaboration with other Clinical Operations groups (Site Engagement and Monitoring Excellence) assist, as necessary, in the preparation and coordination of site monitoring visits, ensuring compliance with monitoring plans and resolution of site-related issues
• Stay updated with relevant regulations, guidelines, and industry best practices pertaining to oncology clinical trials, ensuring compliance, and implementing necessary changes as required

Qualifications

• An Advanced Degree without experience or Bachelor's degree with 2 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline)
• Ability to communicate in multiple languages required.
• Previous experience working as a Clinical Trials Associate, Study Coordinator, or in a similar role within the pharmaceutical, biotechnology, or CRO industry is preferred
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and prioritize workload effectively
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems
• Excellent written and verbal communication skills, with the ability to effectively interact with study team members and internal / external stakeholders
• Ability to work independently as well as collaboratively in a team-oriented environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project)
• Adaptability and willingness to learn and embrace new technologies, processes, and industry trends

The expected hourly range for this role is $50 to $60.50 depending on skills, competency, and the market demand for your expertise.