Sub Investigator - Canoga Park SUMMARY: The Sub-Investigator is a member of the clinical research trial team who supports the Principal Investigator in identifying eligible research patients, performing medical assessments and the medical decisions needed for their treatment. The Sub-Investigator is under the guidance and direct supervision of the site Principal Investigator MD. ESSENTIAL DUTIES AND RESPONSIBILITIES: -Comply with all company policies, procedures, and conduct. -Strictly adhere to confidentiality and compliance standards. -Review medical histories and concomitant medications of study subjects. Confirm inclusion and exclusion study criteria. -Field subject questions related to the investigational product, study procedures and health. -Provide medical oversight required for medically attended events such as vaccinations and infusions. -Maintain GCP and study specific training requirements. -Oversee aspects of clinical trials as directed by the site Investigator MD. -Perform clinical study-related procedures. -Make medical judgements and other decisions on behalf of the Investigator MD. -Meet all study protocol requirements and deadlines. -Perform accurate and timely documentation in eSource. -Assist in answering queries and documentation in eSource. EDUCATION and EXPERIENCE: -Advanced degree as a MD, PA-C or Nurse Practitioner, required. -Active and unrestricted license in the state of practice, required. -Prior experience in pharmaceutical research, clinical trials or academia is highly desirable. -Proficiency in research methodologies, data analysis software and statistical tools. -Strong analytical and critical thinking skills for research design and data interpretation. -Excellent written and verbal communication skills for preparing research reports and presentation of findings. -Thorough understanding of research regulations, guidelines, and standards (i.e. FDA, ICH, GCP). -Flexibility to adapt to evolving research priorities and changing project requirements. -A proven ability to multi-task in a rapidly changing environment. CERTIFICATES, LICENSES, REGISTRATIONS: -Current license as a Medical Doctor, Physician Assistant or Nurse Practitioner as required by state law.
Sub Investigator • Long Beach, CA, United States