Clinical Trial Associate, APAC (CONTRACT)
About The Position
As a Clinical Trials Associate, APAC in Oncology, you will support the planning, coordination, and execution of insourced global Phase I–III clinical studies within the oncology portfolio. The position supports trial operations in a dynamic, collaborative environment and contributes to the development of therapies for life-threatening diseases. The role requires onsite presence at least three days per week, or more as business needs require, at either the Jersey City, New Jersey, or Millbrae, California office. Bilingual fluency in English and Mandarin, Cantonese, Japanese, or Korean is required to interact with locally based trial sites in Asia; candidates without this qualification will not be considered.
Requirements
- Advanced degree with no experience, or a bachelor's degree with two years of experience in a relevant field such as life sciences, healthcare, or a related discipline.
- Bilingual fluency in English and Mandarin, Cantonese, Japanese, or Korean.
- 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.
- Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent written and verbal communication skills and the ability to interact effectively with internal and external stakeholders.
- Ability to work independently and collaboratively in a team-oriented environment.
- Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Project.
- Adaptability and willingness to learn and embrace new technologies, processes, and industry trends.
Nice To Haves
- Previous experience as a Clinical Trials Associate, Study Coordinator, or in a similar role in the pharmaceutical, biotechnology, or CRO industry.
Responsibilities
- Assist with preparing and maintaining essential study documents, including protocols, informed consent forms, case report forms, and other trial materials.
- Collaborate with cross-functional teams to complete study start-up activities, including 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 materials.
- Assist with reviewing and resolving data queries to ensure data accuracy and completeness in electronic data capture systems.
- Work with the TMF Operations team to maintain trial master files and study documentation in accordance with regulatory requirements and internal SOPs.
- Facilitate communication among study team members, investigators, and site personnel through regular correspondence and timely distribution of study information.
- Support monitoring and tracking study progress, including patient recruitment and enrollment, to help ensure adherence to timelines and milestones.
- Work with Site Engagement and Monitoring Excellence groups, as needed, to prepare and coordinate site monitoring visits and address site-related issues in accordance with monitoring plans.
- Stay current with regulations, guidelines, and industry practices for oncology clinical trials, ensuring compliance and implementing necessary changes.
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What This Job Offers
Career Level
Entry Level
