Summary

Education and Credentials

• College degree in relevant field or equivalent years of direct industry related experience.

Experience

• At least 3 - 8 years of industry experience.

Skills

• Must have good communication skills (both oral and written).
• Ability to work in cross-functional team.
• Willingness to adapt to changing priorities and assignments.
• Familiarity with Microsoft Suite of applications including Word, Excel, Project, and PowerPoint.
• Efficient, organized, and capable of multitasking.
• Working knowledge of GCP standards, ICH, and Federal Regulations.
• Process oriented with a strong attention to detail.
• Self-motivator.
• Team player who thrives in fast-paced environment.

Responsibilities

• Participate in study team meetings (planned and/or on an ad hoc basis)，support in the planning, organization, and follow-up of meetings as needed, and produce and track internal meeting agenda, minutes, and action items when necessary.
• Compile, distribute, collect (for some studies), and review for completeness, Investigator Initiation Packets and Regulatory Documents required for site initiation/investigational product release. 
• For some studies, create and maintain internal study activity trackers and study logs, (i.e., Study Site Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs, etc.).
• Review vendor/Investigator site documents/plans (e.g., monitoring plan) for legibility, typographical errors, and conformity to available source documentation (i.e., applicable SOPs, study protocol, etc.).
• For some studies, assist with start-up activities (i.e., development of informed consent and other study related documents).
• Create, file, track, QC, and archive the TMF, including filing and maintenance of electronic study files, as needed, as well as general study materials.
• Track the processing of Confidentiality, Consulting, and Study Agreements.