Job Description
• Must meet all requirements for CPA grade 24 position and have demonstrated proficiency in all relevant areas
• Provide input and assist with harmonization of Clinical Operations databases and tracking tools
• Assist in maintaining clinical information and training of Clinical Operations personnel in the clinical trials management system (GILDA)
• Serves as CTMA back up providing verbal and written communication with study personnel
• Tracks and prepares study-specific information utilizing databases, spreadsheets, and other tools
• Reviews and participates in the quality assurance of data or documents
• Arranges meeting logistics, agendas and assists with minutes
• Interacts with other departments, as directed, to complete assigned tasks
• May assist with monitoring visits under the direct supervision of senior staff
• Assists with the planning and facilitation of investigator meetings and, when applicable, provides onsite support during the meetings
• Knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures
• Must be familiar with Word, PowerPoint, and Excel
• Travel may be required
Qualifications
• At least 1+ year of experience and a BS or BA in a relevant scientific discipline
• At least 1+ year of experience and an RN (2 or 3 year certificate)
Other Details:
• Ability to take direction from senior team members
• Collaborative demeanor
• Great organizational skills
• Strong computer technical skills with regards to word processing and spreadsheet development
• Looking for someone:
- Task oriented
- Forward thinking
- Organized
- 1-2 years of relevant experience or in similar role
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (650)-399-0891
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