Senior Clinical Research Associate – Pool
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Job Description
Senior Clinical Research Associate managing clinical sites for Vanguard Clinical. Responsible for monitoring clinical data in Phases 1, 2, and 3 of trials.
Responsibilities:
- Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites
- The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs)
- Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits
- Main point of contact between assigned sites and Sponsor
- Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements
- Delivers high quality and timely reports following each monitoring visit
- Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines
- Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites
- Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites
- Manages query resolution process with clinical sites and data management groups
- Travel of up to 75% may be required, including globally
- Quarterly travel to San Diego headquarters required, if not residing locally.
Requirements:
- 5+ years of independent clinical monitoring experience preferred
- Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively
- Must exercise sound judgment and take initiative
- Ability to work independently with minimal supervision while producing accurate high quality and timely work
- Must be able to work effectively within a team environment (independently and collaboratively)
- Excellent written and verbal communication skills including strong professional presentation skills
- Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements
- Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.)
- Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines
- Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred.
Benefits:
- health insurance
- 401k retirement plan
- paid days off
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