Sub Investigator at Kelly Science, Engineering, Technology & Telecom

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.