Shift Schedule:
Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic, and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.
Description:
• The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.
• 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 procedures
• Performs all study responsibilities in compliance with the IRB approved protocol
• Reviews screening documentation and approves subject for admission to study
• Reviews admission documentation and approves subject for randomization
• Interprets ECGs within agreed Sponsor timeline
• 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
• Communicated 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
•They should be able to work and thrive in a team-based environment.
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