... profile. Proactively identify risks to quality and compliance and develop and implement mitigation plans to address these risks. Ensures current investigator and site staff contact details are ...

... assess protocol and regulatory compliance and handles required documentation. Manages procedures and ... Duties and Responsibilities:** Monitors investigator sites with a risk-based monitoring approach ...

... within approved parameters both investigator grant budget negotiation parameters, contractual terms and ... , established process with sites and follows established escalation routes. Ensures compliance to ...

... target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance ... experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+years ...