CRA phase II-III
Our client is a global top 10 pharma company located at the east side of Antwerp.
Studies are mainly phase II and phase III studies.
This function is office based.
The CRA is responsible for the proper conduct of the study according to protocol, ICH-GCP and all applicable requirements
- Manage trials ensuring compliance with protocol, Company SOPs, ICH-GCP and national regulatory requirements, local patient recruitment targets and financial agreements
- Perform all trial-specific duties and activities assigned according to the current list of roles and responsibilities
- Ensure accuracy, validity and completeness of data collected at investigational sites that meet clinical objectives and protect patient safety
- Primary local company contact point for investigational site, monitoring and managing site activities on a daily basis
- Prepare and submit Visit Reports punctually to Local Trial Manager for review
- Report directly to a functional manager
- Perform and coordinate ongoing trial-specific training for investigational site staff
- Assist in training of company staff as required
- Works closely together with the LTM/PM and CTAs at the local level Profile
- Medical, para-medical or other biologically related scientific education at university level.
- Experience and proficiency in the conduct of clinical trials
- Ability to manage and support the activities of the investigational site staff and to contribute to the local trial team
- Have a good command of spoken and written Dutch, French and English, cultivate excellent relations with investigational site staff and be a proactive, enthusiastic member of the local Clinical Trials team
- Ability to organize multiple priorities and projects within area of responsibility
- Understand and use a range of computer-based systems to track, monitor and report on investigational site activity and status
- Ability to anticipate and resolve investigational site-related problems
- Willingness to travel with occasional overnight stay away from home