Summary: Provides 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. Performs duties in accordance with company’s values, policies, and procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.
On call responsibilities:
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.
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 (GCP) and FDA regulations governing conduct of clinical trials. Must be willing and able to take call and work weekend shifts.
Ability to read and interpret documents such as safety rules, Standard Operating Procedures (SOPs), Work Instructions (WIs), procedural manuals, governmental and clinical regulations, and similar documents. Able to communicate effectively to employees and management groups and in group meeting settings. Must be able to communicate effectively with sponsors and vendors.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
Good judgment, initiative, problem solving and leadership skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel.
Certificates and Licenses:
Current unrestricted license to practice medicine in the State of California. Current Advanced Cardiac Life Support (ACLS) certification or ability to be certified within one month of employment. GCP training is required and will be provided by the company.
The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.
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.
The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.