Clinical Trial Associate - Oncology

Company Description

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 disease. 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 of proteins as drug targets.

Position

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.

About You

You play a key role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. Your primary responsibilities will include ensuring regulatory compliance, maintaining trial documentation, and facilitating effective communication among cross-functional teams. You have strong communication skills and a passion for advancing care to patients.

Responsibilities

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

• Assist in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems
• Support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones
• Coordinate and track the distribution, collection, and reconciliation of trial supplies, investigational products, and study 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
• In collaboration with TMF Operations team, 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 organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings
• 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

Bachelor's or advanced degree in a relevant scientific discipline (e.g., Life Sciences, Pharmacy, Nursing, or Medicine)

• 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.
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and prioritize workload effectively
• Adaptability and willingness to learn and embrace new technologies, processes, and industry trends.
• Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements
• Previous experience working as a Clinical Trials Associate, Study Coordinator, or in a similar role within the pharmaceutical, biotechnology, or CRO industry is preferred
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project)
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems

t Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• Enhanced parental leave benefit
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• 401k plan with company matching
• Daily subsidized lunch program when on-site
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Generous paid time off and holiday policies

The expected salary range for this role is $99,000 to $114,000, depending on skills, competency, and the market demand for your expertise.