Job Description
Project involvement will be in an administrative role.
• Provides administrative support to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File (including RDMS) for studies on an as needed basis.
• The position entails work under general supervision for routine tasks and with detailed instructions on new assignments.
• Tracking and preparing study-specific information utilizing databases (GILDA, DataVision), spreadsheets, and other tools.
• Distributes updated study related documents (i.e. Investigative Brochures, package inserts) to study teams and internal departments as requested by the CTMA or CTM.
• Under close supervision reviews and participates in the quality assurance of data or documents including and not limited to GILDA and DataVision.
• Arranges meeting logistics.
• Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks).
Qualifications
Typically requires a BS or BA in a relevant scientific discipline.
• 2+ years of experience and an Associate’s degree.
• Must be familiar with Word, Outlook, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
Skills/Experience requirements:
• Excellent verbal and written communication skills and interpersonal skills are required.
• Must be able to work both independently and as part of a team.
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 # - (732)-844-8715
Gold Seal JCAHO Certified ™ for Health Care Staffing
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