A BDN client is looking for (4) Senior CRA candidates to take on the responsibilities of their pivotal IDE study with a focus on, on-site management inclusive of clinical monitoring and data collection ensuring the quality and integrity of the data in accordance with the protocol, internal SOP’s, monitoring plan, GCP and ICH guidelines. This person will act as the primary site contact and site manager throughout all phases of a clinical research study, taking the overall responsibility of allocated sites. Each CRA must be solely focused within the Medical Device industry as this is a HIGH risk, Class III Device with a respiratory (Pulmonary) focus. The consultant will be responsible for all aspects of clinical site management, monitoring case report forms, and electronic data for quality, completeness, and accuracy.
Interacting with data management and study sites to reconcile queries in a timely fashion is desired. A Bachelor's Degree in a Biological/Health Sciences field is required for this role. The candidates should have the ability to travel domestically (approximately 50% of working time) for this role.