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Clinical Trials Nurse Practitioner

Company: LanceSoft Inc
Location: Peoria
Posted on: January 25, 2023

Job Description:



The Clinical Trials Nurse Practitioner delivers patient care services in a retail clinic environment. You will work in collaboration with a dedicated team of professionals as you independently provide holistic, evidenced-based care inclusive of accurate assessment, diagnosis, treatment, management of health problems, health counseling, and disposition planning for our patients, who are age 18 months and above. Encounters are documented utilizing an electronic health record (EHR). Clinical Trials Nurse Practitioner report directly to the Senior Practice Manager.

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 studyrelated 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 studyrelated 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 participants 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 PIs clinical research team


Position Summary:

The Clinical Trials Nurse Practitioner delivers patient care services in a retail clinic environment - all work will be performed in a Client location. You will work in collaboration with a dedicated team of professionals as you independently provide holistic, evidenced-based care inclusive of accurate assessment, diagnosis, treatment, management of health problems, health counseling, and disposition planning for our patients, who are age 18 months and above. Encounters are documented utilizing an electronic health record (EHR). Clinical Trials Nurse Practitioner report directly to the Senior Practice Manager.

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 studyrelated 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).

65 hrs in a 2 week period 3 days one week, 4 days the next with every other weekend commitment
Sample: Week 1: Monday/Tuesday/Friday/Saturday Week 2: Sunday/Wednesday/Thursday

Hours: Monday-Friday 8:30am 7:30pm with 60 min lunch at 1:30pm
Saturday: 9-5:30pm with 30 min lunch at 1 pm
Sunday: 9-4:30pm with 30 min lunch at 1 pm

Duties:

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 studyrelated 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 participants 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 PIs clinical research team


ADDITIONAL DUTIES

Employee 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 Client initiatives.

Experience:

*Please remember to add the completed Clinical Trials Candidate Questionnaire to the top of each submitted resume.
Prior clinical trials work experience (preferably within past seven years)
Must be a Family Nurse Practitioner / FNP
Minimum of two years of medically-relevant experience or equivalent
Effective verbal, written, and electronic communication skills
Initiative, problem solving ability, adaptability and flexibility
Ability to work without direct supervision and practice autonomously
Is proficient with information management and technology
Capacity to collaborate with professional colleagues as necessary to provide quality care
Basic Life Support (BLS) certification
Take and pass a FIT test with the respirators that Client provides, and to wear the provided respirator mask when protocol requires

Education:

Masters Degree level Family Nurse Practitioner program with current National Board Certification and State of Employment license to practice in the Advanced Practice Nurse role required.

Keywords: LanceSoft Inc, Peoria , Clinical Trials Nurse Practitioner, Healthcare , Peoria, Arizona

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