Eikon Therapeutics - Hayward, CA

posted 3 months ago

Full-time - Entry Level
Hayward, CA
Professional, Scientific, and Technical Services

About the position

Eikon 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. We are seeking a detail-oriented and highly motivated Clinical Trials Associate to join our oncology research team. As a Clinical Trials Associate in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. This role will require onsite presence a minimum of 3 days a week in our Hayward, California office to ensure effective global clinical trial management. In this position, you will 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. You will 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. Your responsibilities will also include supporting the organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings, as well as coordinating and tracking the distribution, collection, and reconciliation of trial supplies, investigational products, and study-related materials. You will be responsible for assisting in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems. In collaboration with the TMF Operations team, you will maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs. Effective communication among study team members, investigators, and study site personnel will be essential, and you will facilitate this through regular correspondence and timely dissemination of study-related information. Additionally, you will support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones. Staying updated with relevant regulations, guidelines, and industry best practices pertaining to oncology clinical trials will be crucial to ensure compliance and implement necessary changes as required.

Responsibilities

  • 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
  • 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.

Requirements

  • 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)
  • 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
  • Ability to work onsite at least 3 days a week
  • Proficient in Mandarin or Japanese or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels)

Benefits

  • 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
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