Clinical Research Coordinator II, Neuroscience (Grant Funded)

CHOC Children's; Orange (CA); On-site; USD 64,000 - 106,000; Full time

Job summary

CHOC Children's in Orange, CA seeks a Clinical Research Coordinator II to support sponsored clinical studies in the Center for Clinical Research. You will ensure compliance with Institutional policy, GCP and ICH guidelines and assist with regulatory submissions and consent processes.

Requirements include an Associate degree (Bachelor's preferred), 3+ years of coordination experience, and strong knowledge of Microsoft Office and Cerner EMR. BLS is expected; hospital pediatric experience is a plus.

Qualifications

• Associate degree required; Bachelor’s degree preferred.
• Experience with clinical research coordination.
• Knowledge of regulatory requirements and ICH-GCP.
• Proven ability to communicate clearly and work under pressure.

Responsibilities

• Coordinate sponsorship studies in accordance with Institutional policy, GCP and ICH guidelines.
• Provide coordinator support for sponsored clinical studies in the Center for Clinical Research.
• Assist management with study documentation, regulatory submissions, and informed consent processes.

Skills

Microsoft Office

Communication

Detail oriented

ICH-GCP knowledge

Regulatory requirements

Education

Associate degree

Bachelor's degree preferred

Tools

Cerner EMR

Job description

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.

Work Location

Orange, California

Work Shift

Day – 08hrs (United States of America)

Environmental Sustainability Statement

Driven by the connection between children's health and a healthy environment, we commit to creating a healthcare model that incorporates environmental sustainability aligned with our mission to protect children's health and patient safety.

Job Summary

Under the direction of Research Institute Management, the Clinical Research Coordinator II is responsible for providing coordinator assistance for sponsored clinical studies within the Center for Clinical Research in accordance with Institutional policy, Good Clinical Practice and ICH guidelines as adopted by the FDA.

Pay Range

Minimum $30.94 Midpoint $40.99 Maximum $51.05

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 three years of clinical research coordination experience.

Preferred: Clinical research experience in a hospital setting and/or pediatric clinical research experience.

Education

Required: Associate degree or equivalent additional experience can be accepted in lieu of education.

Preferred: Bachelor’s degree in a relevant field.

Specialized Skills

Required: Basic knowledge of key Microsoft Office programs (Word, Excel, PowerPoint). Demonstrate strong interpersonal skills. Able to communicate effectively both orally and in writing. Be detail oriented. Able to work under pressure in a fast-paced environment while managing multiple competing priorities. Working knowledge of human subjects’ regulatory requirements, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP).

Preferred: Ability to conduct informed consent. Working knowledge of Cerner or equivalent electronic medical record system. Knowledge of sample identification, processing and storage.

Licensure

Required: Basic Life Support (BLS) - American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 6 months of assuming position. With management approval, the time in which to obtain certification may be extended past 6 months due to extenuating circumstances.

Preferred: Phlebotomy certification. Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator

Work Environments - Functional Demand

Light - Moderate energy level Lift and carry 25-35 lbs. Push/pull 50-100 lbs. (ie. empty bed, stretcher).

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) - Constant 67 or more%, Lifting (Floor to waist level) - Frequent 36-66%, Lifting (Floor to waist level) - Occasional 0-35%, Lifting (Waist level and above) - Constant 67 or more%, Lifting (Waist level and above) - Frequent 36-66%, 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. CHOC will consider for employment qualified applicants with criminal histories, in accordance with the Fair Chance Initiative for Hiring.

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.