Clinical Research Sub Investigator - 211452

We are looking for a licensed PA or NP interested in getting into the exciting and growing field of clinical research. Interested applicants must have a clean PA or NP license.

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.

• Delegates study responsibilities as appropriate to trained study staff
• Monitors safety and well-being of study participants at all times
• Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events
• Interprets ECOs within agreed Sponsor timelines
• Participates in on-call activities as required to ensure adequate medical coverage
• Reviews and evaluates all study data and comments to the clinical significance of any out of range results
• Performs all study responsibilities in compliance with the IRB approved protocol
• Performs physical examinations as part of screening evaluation and active study conduct
• Reviews Investigator's Brochure prior to performing any study related activities
• Ensures informed consent has been obtained prior to performing any study procedures
• Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form
• Provides coverage for the Clinic Principal Investigator
• Provides medical management of adverse events as appropriate
• Communicates with Sponsors and auditors as requested
• Provides ongoing assessment of the study subject/patient to identify Adverse Events
• Documents all findings in subject specific source documents
• Reviews admission documentation and approves subject for randomization
• Reviews screening documentation and approves subjects for admission to study
• Performs all job responsibilities in accordance with standards of Good Clinical Practice
• Completes all study documentation in accordance with the study specific requirements

Qualifications:

• Current NP or PA License