Clinical Trials Nurse Practitioner
Company: LanceSoft Inc
Location: Carlsbad
Posted on: January 27, 2023
Job Description:
Job Description:
Job Title: - - - - - - - - - - - - Clinical Trials Nurse
Practitioner
Location: - - - - - - - - - - - - Carlsbad, CA
Duration: - - - - - - - - - - - -12+ months Contract with possible
extension
-
Job Description:
- California Clinical Trials Schedule:
32 hrs. each week with 8 hr. shifts, working every other
weekend
Sample: Week 1: Monday/Tuesday/Friday/Saturday Week 2:
Sunday/Tuesday/Wednesday/Thursday
- Hours: Monday-Friday 10am-7pm with 60 min lunch at 2 pm
Saturday: 9-5:30pm with 30 min lunch at 1 pm
Sunday: 9-5:30pm 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, paraprofessionals,
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
company's guidelines.
- 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 initiatives.
-
Experience:
- 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 company
provides, and to wear the provided respirator mask when protocol
requires.
-
Summary:
- 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 Principal
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).
-
Education:
- Master's 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.
-
If you believe you're qualified for this position and are currently
in the job market or interested in making a change, please give me
a call as soon as possible at (703) 889-6535.
Keywords: LanceSoft Inc, San Diego , Clinical Trials Nurse Practitioner, Healthcare , Carlsbad, California
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