Clinical Research Coordinator II, Critical Care

Rady Children's Hospital-San Diego; Orange (CA); On-site; USD 36,000 - 56,000; Full time

Job summary

CHOC Children’s in Orange, California seeks a Clinical Research Coordinator II to support multiple pediatric clinical studies under minimal supervision. You will manage feasibility, regulatory submissions to IRB, identify participants, coordinate data/specimens, and archive records per policy.

This mid-level role requires at least three years of experience, an associate degree (bachelor’s preferred), and knowledge of ICH-GCP and regulatory requirements. Cerner EMR experience is a plus.

Qualifications

• Minimum three years of clinical research coordination experience.
• Basic knowledge of key regulatory requirements for human subjects and ICH-GCP.
• Ability to conduct informed consent is preferred.

Responsibilities

• Coordinate and provide support to multiple human subjects (clinical) research projects.
• Prepare materials for IRB submission and regulatory review.
• Identify potential study participants and coordinate collection of data and specimens.
• Maintain accurate study records and archival in accordance with policies.
• Communicate across multiple teams and participate in quality assurance audits.
• Ensure timely data collection and proper study materials management.

Skills

Microsoft Office

Interpersonal skills

Communication

Detail oriented

Regulatory knowledge

ICH-GCP knowledge

Informed consent

Cerner EMR

Sample handling

Education

Associate degree

Bachelor’s degree

Tools

Cerner EMR

Job description

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.

Job Summary

With minimal supervision, the Clinical Research Coordinator II (CRC-II) is responsible for providing coordinator support to multiple human subjects’ (clinical) research projects and is expected to perform all core Clinical Research Coordinator (CRC) responsibilities. Study management includes but is not limited to assessing feasibility of clinical research protocols, preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB), identifying potential study participants, coordinating and collecting research data/specimens, completing study records in an accurate and timely manner, participating in quality assurance audits, managing study materials and supplies, communicating across multiple teams, and archiving records in accordance with appropriate policies and procedures. The CRC-II is the mid-level position in the Clinical Research Coordinator series.

Pay Range

Minimum $26.40 Midpoint $33.00 Maximum $41.25

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 (CCRC).

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.

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.