Functional Service Provider specializing in clinical trial operations throughout the life cycle of drug development.
Clinical Research Associate
Location
Arizona + 14 moreAll locations: Arizona | California | Colorado | Connecticut | Florida | Kansas | North Carolina | Ohio | Oklahoma | Maryland | Massachusetts | Michigan | Tennessee | Texas | Washington
Posted
90 days ago
Salary
$90K - $130K / year
Seniority
Mid Level
Job Description
Clinical Research Associate
Vanguard Clinical, Inc.
• Reporting to the Director - Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites. • The Clinical Research Associate (CRA) will 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. • Other work-related duties, special projects, and/or other functions, as required.
Job Requirements
- Minimum of 2 years of experience in a Clinical Trial Assistant or other supporting project role with high attention to detail (3+ years of clinical monitoring experience preferred).
- Prior experience with oncological trials strongly preferred.
- Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.
- Must exercise sound judgment and take initiative, be able 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 (internal and external audiences).
- 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.
Benefits
- health insurance
- 401k retirement plan
- paid days off
- annual performance bonus
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