Work Location

Orange, California

Work Shift

Day – 08hrs (United States of America)

Why CHOC?

At CHOC, we strive to be the leading destination of children’s health by providing exceptional and innovative care. We are responsible for the overall health of our community’s pediatric population in our hospitals, clinics, and practices. And because of our breadth of care, your career at CHOC can be as diverse and fulfilling as you determine. CHOC’s compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals. Apply now to see where your career at CHOC can take you.

Job Summary

The Clinical Research Regulatory Specialist (CRRS) is responsible for regulatory compliance and submission of regulatory documents for clinical research studies in accordance to institutional policies, study sponsor requirements, state and federal regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s Guideline for Good Clinical Practice (ICH-GCP) as adopted by the U.S. Food and Drug Administration (FDA) (when applicable). The CRRS maintains document management systems to ensure regulatory documents are in a state of continuous readiness for site visits or audits. The CRRS performs quality assurance checks on regulatory files and collaborates and communicates with members of the clinical research team.

Pay Range

Minimum $31.85 Midpoint $42.21 Maximum $52.55

Rate of pay is determined by various factors, including but not limited to knowledge, skills, competencies, experience, education, as well as position requirements.

Experience

Required: Minimum two (2) years of clinical research experience with working knowledge of human subjects’ research regulatory requirements and clinical trials operations.

Preferred: Four (4) years of clinical research regulatory and clinical trials operations experience in a hospital or academic setting or with a Sponsor/CRO.

Education

Required: Associate degree or minimum five (5) years of clinical research experience may be accepted in lieu of education.

Preferred: Bachelor’s degree.

Specialized Skills

Required: Excellent communication and organizational skills and superb attention to detail. Must exhibit strong command of the English language, both written and spoken, and the ability to understand and work with medical terminology. Must be able to communicate well with professionals and with those having no knowledge of medical terminology. Must work well under pressure and meet multiple and sometimes conflicting deadlines. Must demonstrate working knowledge of key Microsoft Office programs (Word, Excel, PowerPoint) applications and various database applications.

Licensure

Required: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s Guideline for Good Clinical Practice (ICH-GCP).

Preferred: Clinical Research Certification (e.g., CIP, CCRP, or CCRP).

Work Environments - Functional Demand:

Sedentary - Very light energy level Lift 10 lbs. box overhead. Lift and carry 15 lbs. Push/pull 20 lbs. cart.

Physical Activity Requirements:

Bending, Carry Objects, Climbing, Keyboard use/repetitive motion, Pinching/fine motor activities, Push/Pull, Reaching forward, Reaching overhead, Sitting, Squat/kneel/crawl (Squad & Knee), Standing, Talk or hear, Taste or smell, Twisting, Walking, Wrist position deviation

Physical Activity Lifting

Lifting (Floor to waist level) - Frequent 36-66%, Lifting (Floor to waist level) - Occasional 0-35%, Lifting (Waist level and above) - Occasional 0-35%

Sensory Requirements:

Color Discrimination, Depth Perception, Far Vision, Hearing, Near Vision

Environment Requirements:

Airborn Communicable Disease, Bloodborne Pathogens, Chemical, Dust Particular Matter, Extreme Noise Levels, Extreme Temperatures, Radiation, Uneven Surfaces or Elevations

Non-Discrimination Statement:

CHOC does not discriminate on the basis of age, race, color, religion, national origin, ancestry, marital status, genetic information, disability, sex, gender (including pregnancy, breastfeeding, childbirth, lactation or related medical conditions), gender identity or expression, medical condition, sexual orientation, veteran status, military or uniformed service member status, or other protected characteristics in accordance with state and federal laws.

We encourage individuals from all backgrounds to apply for positions at CHOC, even if your experience doesn’t align perfectly with the listed qualifications for a particular role, as your unique experience may be a great addition to our culture for another one of our opportunities.

If you desire support or accommodations throughout the Talent Acquisition process, please inform your Talent Acquisition Partner.