Responsibilities include but are not limited to
Patient-Centered Quality and Safety
* Perform all study responsibilities in compliance with the IRB approved protocol
* Document all findings in subject specific source documents
* Provide ongoing assessment of the study subject/patient to identify Adverse Events
* Ensure proper documentation and reporting of all Adverse Events and Serious Adverse Events
* Perform physical examinations as part of screening evaluation and active study conduct
* Provide medical management of adverse events as appropriate
* Complete all study documentation in accordance with the study specific requirements
* Communicate with Sponsors and auditors as requested
* Possess a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form.
* Review Investigator's Brochure prior to performing any study related activities
* Participate in on-call activities as required to ensure adequate medical coverage
* Monitor safety and well-being of study participants at all times
