Vanguard Clinical, Inc.
Functional Service Provider specializing in clinical trial operations throughout the life cycle of drug development.
Senior Clinical Research Associate – Pool
Research AnalystResearch AnalystFull TimeRemoteTeam 51-200Since 2012H1B No SponsorCompany SiteLinkedIn
Location
Arizona + 13 moreAll locations: Arizona, California, Colorado, Florida, Kansas, North Carolina, Ohio, Oklahoma, Maryland, Massachusetts, Michigan, Tennessee, Texas, Washington
Posted
1 day ago
Salary
$125K - $150K / year
Bachelor Degree5 yrs expEnglishGoogle Cloud Platform
Job Description
• 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.
Job 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