Kura Oncology
Clinical Trial Associate
Boston, MA
Sponsorship not specified$87k-$102kDetected 13 days ago
GCPExcelProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationProblem SolvingMicrosoft Office
About the role
- Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
- 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).
Responsibilities
- Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
- 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.
- Support study start-up, conduct, monitoring, and close-out activities to ensure protocol adherence and regulatory compliance.
- Support ordering, tracking, and distribution of investigational product and study supplies
- 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).
- As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.
- The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.
- Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
Requirements
- Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
- Ability to work in a matrix environment
- Experience working in a high-volume environment while maintaining both organization and the ability to prioritize tasks
Compensation
- Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
Benefits
- 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.
Company info
- 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.
- 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.
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This listing is sourced directly from Kura Oncology's careers page and normalized into a canonical job model.