Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s);
Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs);
Serve as the primary resource to the clinical investigator and site staff;
Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams; and
Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ® Monitoring Portal.
Qualifications
Bachelor's degree in a health or science related field and with at least 1 to 5 years of experience in clinical monitoring;
Comprehensive knowledge of practices and procedures relating to all clinical monitoring visit types, including practical application of this knowledge;
Demonstrated ability to act as a Lead CRA (as applicable); Act as a resource for new CRAs and ability to facilitate training and serve as a mentor for new CRAs; and
Implements new ideas/solutions, without prompting, within their authority.
