Senior Clinical Trial Associate

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.

GENERAL JOB FUNCTIONS:

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).

Sr. CTA:

• Highly experienced with using different eTMF systems (e.g., Veeva Vault, etc.)
• Accountable for projects within a clearly defined scope and milestones.
• Accountable for the quality of own work. Works independently and receives a moderate to low level of guidance or direction within clear or even broad guidelines.
• Drive harmonization of processes throughout Clinical Operations, use best practices to improve products or services
• Contribute to mentoring, training and provision of direction and guidance to increase knowledge of new team members / new employees
• Make process improvement suggestions and develop new process approaches
• Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
• Take on additional tasks as assigned by management
• Proficient in using and training other CTAs & CTLs on the financial tools / systems to create accurate financial documents
• Independently execute tasks outlined in the General portion of Essential Job Requirements.
• Close collaboration with CTA Line Manager to align on new concepts, address resource topics, exchange status updates
• Responsible for driving and guiding the respective group, while implementing efficient processes, data driven approaches, tools, and training
• Responsible to conduct and lead CTA trainings and meetings on request
• Responsible to monitor quality and compliance of CTA implemented processes
• Role Model and represent / present the CTA Team to Leadership as well as internal / external functions, if needed

JOB SPECIFICATIONS:

General:

• 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.

Sr. CTA:

• Requires a bachelor’s degree in scientific field plus some to substantial relevant professional experience, and good knowledge and experience in clinical trial management or a substantial amount of professional experience in a clinical research-related position (4 years or equivalent) and/ or additional qualifications that also provides exposure to fundamental clinical research related skills & knowledge
• Ability to mentor and coach junior or new staff
• Advanced knowledge of medical and trial related terminology
• Excellent administrative and coordination skills
• Excellent communication skills – both verbal and written
• Excellent computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook, and TEAMS
• Excellent oral and written communication in English
• Excellent time and priority management, ability to work efficiently under pressure
• Excellent understanding of the policies and procedures of Clinical Operations and of ICH-GCP and current FDA regulations.
• Highly motivated, shows initiative, is proactive and able to work independently as well as in a team
• Proficient Trial Master File experience, including use of different eTMF systems
• Strong organizational and problem-solving skills
• Willing to take on responsibility and accountability, exhibits Leadership skills

The base range for a Senior CTA is $103,000 - $147,900 per year. 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 clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1-mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. 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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