Senior Clinical Trial Associate jobs in United States
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Kura Oncology, Inc. · 4 days ago

Senior Clinical Trial Associate

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Senior Clinical Trial Associate supports the operational execution of clinical trials, ensuring compliance with regulatory requirements and alignment with company objectives.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine
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Comp. & Benefits

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)
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

Qualification

Clinical trial managementETMF systemsRegulatory complianceOncology experienceCRO oversightFinancial tools proficiencyInterpersonal skillsOrganizational skillsCommunication skillsProblem-solving skillsLeadership skills

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
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
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 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

Preferred

Experience in CRO oversight is preferred

Benefits

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!

Company

Kura Oncology, Inc.

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Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.

Funding

Current Stage
Public Company
Total Funding
$1.24B
Key Investors
Bristol-Myers SquibbHercules CapitalEcoR1 Capital
2024-01-24Post Ipo Equity· $150M
2023-06-14Post Ipo Equity· $100M
2022-11-03Post Ipo Equity· $25M

Leadership Team

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Troy Wilson
Co-Founder, CEO and President
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Brian T. Powl
Chief Commercial Officer
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Company data provided by crunchbase