Clinical Trial Associate, Oncology
- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
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.
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.
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.
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 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
- 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
- Bachelor's or advanced degree in a relevant scientific discipline (e.g., Life Sciences, Pharmacy, Nursing, or Medicine)
- 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
- 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 $99,000 to $114,000 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.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.