Clinical Trial Associate, APAC (CONTRACT)

Eikon Therapeutics•Jersey City, NJ

4d•Hybrid

About The Position

Eikon Therapeutics is hiring a Clinical Trial Associate, APAC, in Oncology to support the planning, coordination, and execution of Phase I–III insourced global clinical studies. The role supports study operations and contributes to the development of therapies for life-threatening diseases. It requires onsite presence at least three days per week, or more as business needs require, in either the Jersey City, New Jersey, or Millbrae, California office. Bilingual fluency in English and Mandarin, Cantonese, Japanese, or Korean is required because the role involves interacting with locally based trial sites in Asia; candidates without this qualification will not be considered. The associate supports study start-up, documentation, trial logistics, data review, trial master file maintenance, study communications, progress tracking, and site monitoring coordination. The position involves collaboration with cross-functional clinical operations teams, investigators, and study site personnel, while ensuring compliance with applicable regulations, internal SOPs, and study requirements.

Requirements

Advanced degree with no experience required, or a bachelor's degree with two years of experience in a relevant field such as life sciences, healthcare, or a related discipline.
Fluency in English and one of 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 effectively.
Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Excellent written and verbal communication skills, including the ability to interact effectively with study team members and 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 adopt new technologies, processes, and industry trends.
Ability to work onsite at least three days per week in either Jersey City, NJ, or Millbrae, CA.

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 study documents, including protocols, informed consent forms, case report forms, and other trial-related 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-related materials.
Assist with reviewing and resolving data queries to support data accuracy and completeness in electronic data capture systems.
Maintain trial master files and study documentation with the TMF Operations team in accordance with regulatory requirements and internal SOPs.
Facilitate communication among study team members, investigators, and site personnel through correspondence and timely distribution of study information.
Support monitoring and tracking study progress, including patient recruitment and enrollment, against timelines and milestones.
Assist with preparing and coordinating site monitoring visits with Clinical Operations groups, including Site Engagement and Monitoring Excellence, and help resolve site-related issues.
Stay current on regulations, guidelines, and industry best practices for oncology clinical trials, and support compliance and implementation of necessary changes.