Job Description

Position: Clinical Trial Consultant -Open Position-CA
Type: contract
Duration: 12+ months
Location: Pleasanton, CA

Job Description:

The Clinical Trial Program Consultant will work with a team under direct supervision of the Director of Quality and Regulatory teams. The specific duties may include:

• Monitoring and assessment of events in clinical trials
• Use of Quality monitoring system to correctly log research events
• Communication within and outside of the team to address concerns and out of scope events
• Metric analysis and reporting functions as needed
• Assist with quality monitoring oversight and compliance within the QA group
• Must demonstrate excellent leadership, organizational, interpersonal, and communication skills

Other duties as required to assist with monitoring projects and goals Work Days: Scheduled days and hours are contingent upon departmental needs. Normal schedule: M-F (8:00am 5:00pm). Work Location: Pleasanton, CA

Basic Qualifications:

Bachelor s degree Additional Requirements:

• Must demonstrate excellent organizational, interpersonal, and communication skills.
• Experience with regulatory, quality or legal compliance
• Familiarity with medical terminology
• Proficient in understanding and the application of regulatory requirements and quality compliance AE, SAE, UP and Noncompliance reporting GDP, Google Cloud Platform, ALCOA, HIPAA or legal environment familiarity
• Metrics and data analysis reporting and assessment Preferred Qualifications:
• Must be dependable, punctual, detail-oriented, and able to follow detailed protocols precisely.
• Experience with monitoring or auditing, plus if also involved with FDA-regulated clinical trials.
• Must possess leadership skills and experience as a trainer or team lead or resource
• Must be able to work successfully with a wide variety of internal and external project staff and research participants
• Must exhibit a professional manner with a high degree of courtesy, tact, and sensitivity.
• Must be able to work well independently as well as part of a larger multi-disciplinary research team. Experience with word-processing and spreadsheet software programs preferred.
• Proficiency with Microsoft Office products (Word, Excel, and PowerPoint) and Adobe Acrobat software highly desirable.

Please do reply to me with your updated resume with the hourly rates ASAP

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

• Dice Id: 90803292
• Position Id: 8484632

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