- Professional
- Office in Las Vegas
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 include the following. Other duties may be assigned.
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.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE:
Advanced degree as a MD, PA-C or Nurse Practitioner, required. Deborah Wu Otani Inglewood, CA
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.
Language Skills
Ability to read, analyze and interpret instructions, regulations, protocols, and procedures. Ability to write reports and correspondences. Ability to effectively communicate, present information, and respond to questions from groups of managers, physicians, employees, and participants.
Mathematical Skills
Ability to perform advanced mathematic skills including calculating, adding, subtracting, multiplying, and dividing in all units of measure.
Reasoning Ability
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Certificates, Licenses, Registrations:
Current license as a Medical Doctor, Physician Assistant or Nurse Practitioner as required by state law.
Travel Required: Estimated 99% clinic site work. Potential for an accessional trip to an Investigator Meeting.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, walk, talk and hear. The employee is regularly required to work at a keyboard, computer and phone. Specific vision abilities required by this job include close vision and the ability to adjust focus.
The employee may be required to lift and/or move up to 15 pounds.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.
