Overview
Reference Number: JO-2103-465267
Principal Investigator
Rate: $215,000 – 225,000
Job Type: Permanent
Location: Lincoln
CPL Physicians is working witha world leader in early phase clinical research which has a large facitlity near Phoenix Arizona. They require an experienced physician looking to move into a clincial research role for the post of Principal Investigator.
Ideally you would be a board certified or board eligible physician in family medicine, internal medicine, or emergency medicine. It is essential that you have an Arizona medical license or the ability to gain a license.
Duties:
Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study. Provide input to sponsor as indicated.
Complete FDA 1572 and financial disclosure forms.
Attend study initiation meetings with sponsor.
Communicate with Institutional Review Board during protocol approval process and subject safety issues.
Explain study to subject and answer questions, ensure proper consent, and perform screening examination.
Final review of all screening data and authorization of subjects to be enrolled in the study.
Perform scheduled per protocol, and unscheduled per adverse event, physicals during study conduct.
Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity, and etiology.
Review pre-dose lab work, ECGs, and other study data and determine appropriate action plan based on these results. Review safety data with sponsor.
Compose SAE and other reporting documents as indicated.
Review and sign Case Report Forms and final Clinical Study Reports.
Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines
Data review of all end-of-study data to determine if re-checks are necessary
Safety-monitoring perform end-of-study physical exams and follow-up ongoing adverse events
Case Report Forms review review and sign all case report forms at end of study
Assist in on-site client review of case report forms
This role would particualrly suit an individual looking to move out of routine clinical practice. This would be a full time post with regular office hours and will offer support and trainign in building a career in clincial research. There would be an expectation that the successful candidate woudl be able to move up within this international business and build a pharmaceutical industry career.
For more information on this role please CLICK APPLY and forward an up to date resume.
