Study Start Up Assistant Remote
Job description
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
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