CRA phase I
Our client is a global top 10 pharma company located at the east side of Antwerp.
Studies are phase I 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 phase I 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, preferably phase I 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