Description: bull Serve as a Sub-Investigator clinician for the clinical trials site ensuring all elements of clinical trials work are completed in compliance with standard operating procedures. The Sub-Investigator is under the supervision of the Principle Investigator and is responsible for performing study-related procedures and /or to make important study-related decisions in compliance with the ethical conduct of the study. bull Ability to perform Basic Life Support BLS assistance including but not limited to performing CPR and operating an Automated External Defibrillator AED. PRIMARY DUTIES RESPONSIBILITIES: Responsibilities include but are not limited to Patient-Centered Quality and Safety bull Perform all study responsibilities in compliance with the IRB approved protocol bull Document all findings in subject specific source documents bull Provide ongoing assessment of the study subject/patient to identify Adverse Events bull Ensure proper documentation and reporting of all Adverse Events and Serious Adverse Events bull Perform physical examinations as part of screening evaluation and active study conduct bull Provide medical management of adverse events as appropriate bull Complete all study documentation in accordance with the study specific requirements bull Communicate with Sponsors and auditors as requested bull Possess a working knowledge of GCP/ICH guidelines Clinic SOPs QA/QC procedures and Investigator 1572 Form. bull Review Investigator's Brochure prior to performing any study related activities bull Participate in on-call activities as required to ensure adequate medical coverage bull Monitor safety and well-being of study participants at all times bull Delegate study responsibilities as appropriate to trained study staff bull Educate patients on health maintenance and respond to patient care inquiries bull Document all patient care within an EHR according to company policies and procedures bull Provide care and coordination of our patients with internal and external colleagues including the broader patient centered medical home ensuring the highest standard of care is provided for all patients and at all times bull Effectively work within a patient care team including fellow Providers Collaborative Physicians para-professionals Pharmacists and other members of the health care team The Sub-Investigator/Co-Investigator may also perform all or some of the functions of the Principal Investigator PI as delegated by the Principal Investigator. The sub-investigator/co-Investigator is under the supervision of the PI and is responsible for performing study-related procedures and /or to make important study-related decisions in compliance with the ethical conduct of the study. Responsibilities include but are not limited to: bull General study coordination activities bull Review participants inclusion and exclusion criteria bull Collect medical history bull Physical exam bull Collect vitals: body temp pulse oximetry respirations heart rate etc. bull Specimen collections and diagnostic assays bull Facilitate patient surveys and questionnaires bull Patient education bull Patient scheduling bull Treatment administration bull Liaison with the project management team the PIs clinical research team bull Other activities in support of the conduct of the research protocol in accordance with all Federal State Local and CVS guidelines.
KY license Required.