Study Associate , Clinical Operations

Study Associate I, Clinical Operations

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Employee Value Proposition

The Study Associate (SA) I is responsible for operational study support during study start-up, maintenance, and close-out. The SA I helps with the coordination of project activities, including corresponding with internal and external team members globally, assisting, updating of study trackers and systems and overseeing study documentation and Trial Master File. The SA supports the Clinical Operations department with developing processes and procedures and sharing lessons learned.

• Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies.
• Updates internal study trackers, dashboards, and systems with accurate study information (enrollment, study systems and tools/trackers, study team contact list, etc.).
• Responsible for the review of the TMF plans to ensure consistency across studies and alignment with internal TMF procedures.
• Monitors Trial Master File related KPIs and performs quality review of the eTMF (per CRO oversight plan) while collaborating with internal and CRO study teams to resolve any issues and risks.
• Reviews Monitoring Visit Reports (SEV, SIV, IMV, COV) from the CRO to ensure that sites are in compliance with the study and protocol. Reviews monitoring and other study operation plans and tracks related trends and KPIs.
• Provides support across all study phases, including but not limited to vendor set‑up, enrollment, site-related documentation, and inspection readiness.
• Collaborates closely with study manager to align expectations and study priorities for support.
• Manages access to internal study systems for applicable internal and external study team members.
• Assists with the onboarding of new hires, when applicable regarding system access or internal processes.
• May review and approved site level informed consents as compared to the master informed consent.
• Reviews and approves site budgets and escalates any issues to the study manager.
• Reviews and approves essential documents (green light) for drug release.
• Proactively incorporates learning and recommendations from other teams and practices and promotes standardization and efficiency in operations practices and processes ensuring consistent delivery across studies.

• Associate’s degree or equivalent. Bachelors’ degree in biological sciences is preferred.

• 2 years of relevant clinical trial support or site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry.
• Experience and knowledge of Trial Master File and essential documents.
• Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct clinical trials.
• Has demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
• Attention to details and well organized.
• Solution oriented and exceptional collaboration skills.
• Must possess the ability to multi‑task and effectively prioritize in order to ensure clinical trial goals.
• Recognize potential obstacles and work to resolve them within set timelines.
• Delivers work conscientiously and precisely even when under pressure.
• A team player and able to work in a dynamic environment with attention to high quality results.
• Excellent communication skills both verbal and written.
• Good proofreading skills.
• Takes initiative and utilizes good judgment.
• Ability to effectively present information and respond to questions internally and externally.
• Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.
• Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations and training.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $73,100 - $86,000 annually. This pay…