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Salary: USD 104,000 - 126,000 / annual
Eikon Therapeutics is a biopharmaceutical company using revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. The company's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), featuring microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets.
As a Clinical Trials Associate in APAC 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.
Key responsibilities include:
- 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
- Maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs, in collaboration with TMF Operations team
- 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
- Assist 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
This role requires a minimum of 3 days per week of onsite presence (or more as business needs require) in either the Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence, and high-performance delivery of clinical studies and to support expected significant team growth and collaboration.
CRITICAL REQUIREMENT: This position requires fluency in Mandarin, Cantonese, Japanese, or Korean. Candidates without this qualification will not be considered due to the nature of interacting with locally based trial sites in Asia.
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)
- Fluency in Mandarin, Cantonese, Japanese, or Korean (required)
- 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 (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
