This position requires a NP or PA license in the state of New Mexico.
Clinical Research experience is NOT required.
The Sub Investigator works closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable.
- Performs all job responsibilities in accordance with standards of Good Clinical Practice
- Delegates study responsibilities as appropriate to trained study staff
- Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form
- Reviews Investigator's Brochure prior to performing any study related activities
- Ensures informed consent has been obtained prior to performing any study procedures
- Performs all study responsibilities in compliance with the IRB approved protocol
- Reviews screening documentation and approves subjects for admission to study
- Reviews admission documentation and approves subject for randomization
- Interprets ECOs within agreed Sponsor timelines
- Documents all findings in subject specific source documents
- Provides ongoing assessment of the study subject/patient to identify Adverse Events
- Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events
- Reviews and evaluates all study data and comments to the clinical significance of any out of range results
- Performs physical examinations as part of screening evaluation and active study conduct
- Provides medical management of adverse events as appropriate
- Completes all study documentation in accordance with the study specific requirements
- Communicates with Sponsors and auditors as requested
- Participates in on-call activities as required to ensure adequate medical coverage
- Monitors safety and well-being of study participants at all times
- Provides coverage for the Clinic Principal Investigator
Qualifications:
