Our client is a small rapidly growing companyin the field of respiratory disorders. They are seeking a Lead CRA to work with both internal and external team members, responsible for site qualification, verification and recruitment through to close out.
Liaising with clinical operations team building relationships with clinical sites ensuring site performance.
Responsible for the training and development of more junior CRA's providing SME on the study protocol.
Responsible for CRA performance against KQI's
Addresses non-medical site questions.
Organizes and conducts study specific meetings including the preperation of materials
Performs on site or remote monitoring activities (approx 20% travel)
BS in scientific or health-related field
5 years + clinical research experience with onsite monitoring experience
strong computer skills
Indepth knowledge of ICH/GCP, FDA, MDR and EU regulations
Excellent communication skills both verbal and written