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Taiho Oncology, Inc. · 4 weeks ago

Study Associate I, Clinical Operations

Princeton, NJ

Full-time

Hybrid

Entry Level

$73K/yr - $86K/yr

2+ years exp

Taiho Oncology, Inc. is dedicated to improving the lives of patients with cancer through innovative clinical operations. The Study Associate I plays a crucial role in providing operational support during study start-up, maintenance, and close-out, ensuring effective coordination and documentation throughout the clinical trial process.

BiotechnologyHealth CareMedicalOncologyPharmaceutical

Comp. & Benefits

Responsibilities

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

Qualification

Clinical trial supportTrial Master FileFDA/GCP/ICH guidelinesCommunication skillsAttention to detailCollaboration skillsProblem-solvingPresentation skills

Required

Associate's degree or equivalent

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