Clinical Trial Associate

Essential Job Functions

• Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
• Aid in 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.
• Afford study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
• 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.
• Aid in the 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.

Job Specifications

• 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.

Education and Experience

• Bachelor’s degree in scientific field with no to some professional experience or a substantial amount of professional experience in a clinical research-related position (1-2 years or equivalent).
• Experience in CRO oversight is preferred.
• Strong organization, documentation, and communication skills with an ability to manage multiple projects simultaneously.

Compensation and Benefits

The base range for this role is $87,266 - $102,000. 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:

• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• Participation in an annual target bonus

The Kura Package includes:

• Career advancement/ development opportunities
• Generous benefits package with a variety of plans available with a substantial employer match
• 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice.