* 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.
* 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
* 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
* Delegate study responsibilities as appropriate to trained study staff
* Educate patients on health maintenance and respond to patient care inquiries
* Document all patient care within an EHR according to company policies and procedures
* 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
* 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:
* General study coordination activities
* Review participant's inclusion and exclusion criteria
* Collect medical history
* Physical exam
* Collect vitals: body temp, pulse oximetry, respirations, heart rate, etc.
* Specimen collections and diagnostic assays
* Facilitate patient surveys and questionnaires
* Patient education
* Patient scheduling
* Treatment administration
* Liaison with the project management team the PI's clinical research team
* Other activities in support of the conduct of the research protocol in accordance with all Federal, State, Local, and CVS guidelines.