- 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:
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
- 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
- Employees may be required to complete or be responsible for additional job duties as assigned by Primary Investigator, Clinical Trials Operational Lead, Senior Practice Manager, or Area Director.
- At the direction of your manager, you may be asked to perform duties outside of the typical day-to-day functions of the role to support various other initiatives.
- Master's Degree level Family Nurse Practitioner program
- Current National Board Certification and State of Employment license to practice in the Advanced Practice Nurse role required
- Prior clinical trials work experience
- Minimum of two years of medically-relevant experience or equivalent
- APRN - CNP in the state of CT
Schedule: 65 hrs in a 2 week period - 3 days one week, 4 days the next with every other weekend commitment
Monday-Friday 8:30 am - 7:30 pm with 60 mins. lunch at 1:30 pm
Saturday: 9:00 am - 5:30 pm with 30 mins. lunch at 1:00 pm
Sunday: 9:00 am - 4:30 pm with 30 mins. lunch at 1:00 pm
Job Duration: 05/29/2023 to 01/27/2024
Work Set-up: Fully Remote