Clinical Trial Associate, APACJersey City, NJ; Millbrae, CAEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. 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 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. 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 SOPsFacilitate 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
- At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
- The expected salary range for this role is $104,000 to $126,000 depending on skills, competency, and the market demand for your expertise.
- Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
