Senior Clinical Research Associate

Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.

We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.

Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.

Position Overview:

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).

Essential Duties & Responsibilities:

• 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.

Experience & Skills:

•  5+ years of independent clinical monitoring experience 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.

Education:

Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.