Sub Investigator

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.

• 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 judgments 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.

• 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.

• Current license as a Medical Doctor, Physician Assistant or Nurse Practitioner as required by state law.

401 (k) Retirement Plan, Medical, Dental, and Vision Insurance, Paid Time Off (PTO), Floating Holidays And more!