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Clinical Trial Associate

Company: Planet Pharma
Location: South San Francisco
Posted on: May 3, 2021

Job Description:

Project Overview:

The CRA will assist with multiple clinical studies in the Digital Biomarkers and Mental Health programs. This includes ongoing studies and studies that are planned. The CRA will assist the Clinical Operations Specialists in overall management of clinical studies including (but not limited to): study design, initiation, monitoring and close-out). The CRA will also assist with other regulatory requirements (e.g. IRB submissions).

Overall Responsibilities:

* Assist in the preparation, handling, distribution, filing, and archiving of clinical study documentation * Accurately maintain Trial Master File documentation per internal requirements to ensure inspection readiness * Support the preparation, handling, tracking, and distribution of Clinical Trial Supplies * Assist with the tracking, and management of Case Report Forms (CRFs), and data queries * Support monitoring visits and resolution of monitoring findings * Assist Clinical Operations team members with study-related duties as necessary

Skill/Experience/Education

Mandatory

* BA/BS degree 4 years of experience in clinical research * Strong written and verbal skills * Effective time management and organizational skills * Attention to detail and accuracy in work * Ability to maintain effective working relationships with coworkers, managers and clients * Computer skills including Microsoft Word, Excel, PowerPoint and Google Docs. * Working knowledge of applicable clinical and regulatory requirements (i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)

Keywords: Planet Pharma, South San Francisco , Clinical Trial Associate, Other , South San Francisco, California

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