Clinical Operations Associate

TL;DR

Clinical Operations Associate: Assisting with day-to-day management of clinical studies with an accent on supporting the Clinical Operations Team. Focus on compiling, distributing, and tracking study-related documents and materials.

Location: United States

Company

hirify.global is a pharmaceutical company.

What you will do

• Participate in study team meetings and track internal meeting agenda, minutes, and action items.
• Compile, distribute, collect, and review Investigator Initiation Packets and Regulatory Documents.
• Create and maintain internal study activity trackers and study logs.
• Review vendor/Investigator site documents/plans for legibility and conformity to source documentation.
• Assist with start-up activities, including 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.
• Track the processing of Confidentiality, Consulting, and Study Agreements.

Requirements

• College degree in a relevant field or equivalent years of direct industry-related experience.
• At least 3 - 8 years of industry experience.
• Must have good communication skills (both oral and written).
• Ability to work in a cross-functional team.
• Willingness to adapt to changing priorities and assignments.
• Working knowledge of GCP standards, ICH, and Federal Regulations.

Culture & Benefits

• Efficient, organized, and capable of multitasking.
• Process-oriented with a strong attention to detail.
• Self-motivator.
• Team player who thrives in a fast-paced environment.