Vanguard Clinical, Inc.
Functional Service Provider specializing in clinical trial operations throughout the life cycle of drug development.
Clinical Research Associate
Research AnalystResearch AnalystFull TimeRemoteTeam 51-200Since 2012H1B No SponsorCompany SiteLinkedIn
Location
Arizona + 14 moreAll locations: Arizona, California, Colorado, Connecticut, Florida, Kansas, North Carolina, Ohio, Oklahoma, Maryland, Massachusetts, Michigan, Tennessee, Texas, Washington
Posted
1 day ago
Salary
$90K - $130K / year
Bachelor Degree2 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 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