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Position Purpose:

• This in-house position is responsible for supporting the Study Start Up Team at Client.

Primary Responsibilities:

• Assists with administrative tasks across multiple clinical trials for the Study Start Up Team.
• Uploads and classifies essential documents to electronic Trial Master File (eTMF) accurately and on time for site greenlight.
• Performs background checks for Principal and Sub-Investigators working on Client studies.
• Manages site contacts in clinical trial management system for sites currently in start-up.
• May be responsible for updating metrics in clinical trial management systems.
• May assist with preparation of study start up packets for clinical trial sites.
• May review essential documents for accuracy and completeness.
• Provides regular updates and escalates issues to Manager, SSU and/or SSU Specialist.
• Manages time across multiple clinical studies and escalates issues to line manager.
• Complete training assigned by Client and/or EP, as necessary, including general training requirements,
• SOPs, and system/process related training.
• Adhere to EP and Client SOPs and processes.

The Individual:

Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.

Pharmaceutical or biotechnology industry experience, preferred.

Knowledge of clinical start-up process and requirements.

Previous start up unit experience, preferred.

Oncology clinical research experience, preferred.

Requires effective organizational and time management skills.

Able to multi-task under limited direction and on own initiative.

Strong communication and inter-personal skills.

Highly responsive and proactive, a team player.

Knowledge of CFR and ICH/GCP requirements, preferred.

Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.

Proficiency in written and spoken English