Physician Sub-Investigator Consultant

Position Summary

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.

Core Essential Skills

• ABIM board certified (and verified) in internal medicine (and may be subspecialized as well).
• Experience in clinical medicine which may include hospital-based or clinic-based practices, for at least one year after their terminal training.
• Clean DEA registration and unrestricted license to practice medicine in Florida.
• MD with board certification in internal medicine, active FL medical license, unrestricted license

Screenings

• Basic Background check 11 Panel Drug + Fentanyl

Description

Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form Reviews. Reviews Investigator’s Brochure prior to performing any study procedures. 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. Provides physical examinations as part of screening evaluation and active study conduct. 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.

Site Key Words

• Physician
• Investigator
• Clinic Principal Investigator