The posting
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.
To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
ESSENTIAL JOB FUNCTIONS:
Job Summary:
The Clinical Trial Associate (CTA) supports the operational execution of clinical trials from start-up through close-out. This role partners closely with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials are conducted efficiently, compliantly, and in alignment with program and company objectives.
Key Responsibilities
- Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
- Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
- Collect, track, and review investigator site regulatory documentation (e.g., FDA Form 1572, FDFs, CVs, medical licenses, and study-specific documents) for completeness and accuracy.
- Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH-GCP and company SOPs.
- Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
- Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
- Ensure clinical trial management systems (company and/or CRO systems) are kept current in collaboration with the Clinical Trial Leader (CTL).
- Support study start-up, conduct, monitoring, and close-out activities to ensure protocol adherence and regulatory compliance.
- Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
- Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
- Provide operational and financial support, including purchase orders, contract setup, invoice processing, and tracking of study budgets.
- Assist with development, review, and maintenance of study documents (e.g., protocols, ICFs, CRFs, monitoring plans, manuals).
- Review study reports and operational metrics for accuracy and quality.
- Maintain study team lists, SUSAR distribution lists, databases, and departmental systems; support study team training activities.
- Support inspection readiness, compliance activities, clinical trial insurance processes, and patient recruitment material review.
- Collaborate cross-functionally with internal and external stakeholders to support successful trial execution.
- Perform additional duties as assigned.
- Experienced with using different eTMF systems (e.g., Veeva Vault, etc.)
- Accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or even solves problems of low complexity independently by identifying and selecting solutions and by analyzing factual information.
- Contribute to harmonization of processes throughout Clinical Operations, use best practices to improve products or services
- Contribute to process improvement suggestions
- Take on additional tasks as assigned by management within a job discipline or specialized technical expertise
JOB SPECIFICATIONS:
- Ability to work in a matrix environment
- Experience working in a high-volume environment while maintaining both organization and the ability to prioritize tasks
- Good understanding of the responsibilities and needs of other functions in a clinical trial
- Reliable, conscientious, and confidential
- Strong interpersonal skills and ability to deal with people at all levels with sensitivity and tact as well as ability to collaborate across
- Some experience in oncology
- Experience in CRO oversight is preferred.
- Strong organization, documentation, and communication skills with an ability to
- Ability to travel based on assigned study needs, typically minimal travel required.
- Requires a bachelor’s degree in scientific field with no to some professional experienced or a substantial amount of professional experience in a clinical research-related position (1-2 years or equivalent) and/ or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
- Good administrative and coordination skills
- Good communication skills – both verbal and written
- Good knowledge of medical and trial related terminology
- Good oral and written communication in English, other languages an asset
- Good organizational and problem-solving skills
- Good time and priority management, ability to work efficiently under pressure
- Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP and current FDA regulations.
- Motivated, shows initiative, is proactive and able to work independently as well as in a team
- Strong computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook, and TEAMS
- Familiar with Trial Master File handling, including use of different eTMF systems
- Willing to take on responsibility
The base range for this role is $85,000 - $98,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
#LI-RM1
Kura’s Values that are used for candidate selection and performance assessments:
- We work as one for patients
- We are goal-focused and deliver with excellence
- We are science-driven courageous innovators
- We strive to bring out the best in each other and ourselves
The Kura Package
- Career advancement/ development opportunities
- Competitive comp package
- Bonus
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 18 Holidays (Including Summer & Winter Break)
- Generous Benefits Package with a variety of plans available with a substantial employer match
- Paid Paternity/Maternity Leave
- In-Office Catered lunches
- Home Office Setup
- Lifestyle Spending Stipend
- Commuter Stipend (Boston Office)
- Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!
Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.
Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.
Kura developed and is commercializing KOMZIFTI® (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.
Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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