Clinical Research Associate

JOB SUMMARY:

This role will include facilitating clinical research by following strategies and tactics formulated in association with other Clinical Affairs staff to meet departmental objectives.

Responsibilities:

• Site Management: initiation, monitoring, and closeout and the ability to assist with study problem identification to ensure timely study progression.
• Study Startup Activities: site identification and qualification, creation of study binders, study logs, work instructions, case report form, and other study-related materials.
• Clinical Trial Data Management: Identify data discrepancies and write queries for clarification of data.
• Familiarity with the utilization of paper-based and electronic data capture systems for the collection of study data.
• Trial Master File (TMF) Maintenance: collect and file essential clinical trial documents
• Willingness to provide support for other department duties, projects, and tasks as assigned in an accurate and timely manner.

EDUCATION AND EXPERIENCE:

REQUIRED:

• BA/BS in Biology, Chemistry, or scientific field
• 3 – 5 years of experience in the Clinical Research field
• Understanding of FDA regulations regarding clinical trials to include ICH GCP guidelines.
• Requires a minimum of 25% travel in support of clinical study activities. 
• Strong written and verbal communication skills.
• Strong computer skills including MS Office Suite (including Outlook, Word, Excel, and PowerPoint),
• Familiarity with clinical research activities and medical terminology.

PREFERRED:

• Familiarity with electronic data capture systems (eDC), clinical databases, Case Report Forms, edit checks, query resolution, and resolving data management issues.
• Ability to work in a moderate to high-stress level environment.
• Ability to work independently to complete assignments under minimum supervision in an accurate, effective, and timely manner; ability to meet project deliverables.
• Ability to multi-task, work well with others in a collaborative team environment; ability to identify priorities, organization priority shifts, and exercise efficient time management skills.