Job ID: 289177575
Last Updated: 4/13/2015
Clinical Research Physician
Profil Institute for Clinical Research
Summary: The Clinical Research Physician will provide medical leadership, oversight, and management of human clinical trials while ensuring the integrity of the studies and the safety and well-being of human subjects. Perform duties in accordance with companys values, policies, and procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the companys sole discretion.
Participate in clinical trials as Principal Investigator and Sub-Investigator.
Provide input to the Science team for protocol development; review and edit protocols as needed.
Participate in regular study meetings with staff and sponsors.
Lead or participate in data review and discussions regarding results.
Review and edit clinical study reports as needed.
Perform medical histories, physical exams, and protocol based assessments for qualification of subjects for studies.
Determine suitability of study volunteers for enrollment.
Admit, discharge, and monitor subjects including reviewing lab results, EKGs, and telemetry.
Review training documents and complete any accompanying quizzes.
Supervise mid-level practitioners.
Assess and manage adverse events and medical emergencies.
Participate in safety and dosing assessments.
On call responsibilities:
Share in rotation of weekly call schedule.
Medical Degree plus at least one year of clinical experience in adult medicine. Experience in clinical trials and/or drug development preferred.
Skills, Knowledge, and Abilities:
Knowledge of current principles, methods, and procedures for the delivery of medical evaluation, diagnosis, and treatment. Understanding of basic physiology of glucose homeostasis, diabetes, and obesity. Ability to manage medical care of diabetic subjects, obese subjects, and other common medical problems, including medical emergencies. Thorough understanding of Good Clinical Practices and FDA regulations governing conduct of clinical trials. Must be willing and able to take call and work weekend shifts.
Certificates and Licenses:
Current unrestricted license to practice medicine in the State of California. Current DEA license. Current Advanced Cardiac Life Support (ACLS) certification or ability to be certified within one month of employment.
Manage and oversee mid-level practitioners. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Supervise the overall conduct of studies when serving as Principal Investigator for the studies.
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