Supervisor, Clinical Research Coordinator, Neonatology

CHOC Children's; Orange (CA); On-site; USD 91,000 - 149,000; Full time

Job summary

CHOC Children's in Orange, CA seeks a Clinical Research Coordinator Supervisor to independently manage multiple pediatric clinical research projects and mentor a team of coordinators. Responsibilities include regulatory submissions, data collection, and study-related communications across teams.

The role requires leadership, strong ICH-GCP knowledge, and experience with IRB processes in a hospital setting. This position is based on-site in Orange, CA.

Qualifications

• Minimum six (6) years of clinical research coordination experience.
• Bachelor’s degree or equivalent; Master’s degree preferred.
• ACRP-CP/CCR P/CCRC certification within 12 months; BLS within 6 months.

Responsibilities

• Coordinate multiple clinical research projects with regulatory compliance.
• Mentor, educate, and lead junior staff and coordinators.
• Prepare materials for IRB submissions and regulatory reviews.
• Manage study data, records, and project meetings; ensure quality audits.

Skills

MS Office

ICH-GCP knowledge

Informed consent

Leadership/mentorship

Communication skills

Education

Bachelor's degree or equivalent experience

Master's degree in a relevant field

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)

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.

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

The Clinical Research Coordinator Supervisor (CRC-Su) functions independently and is responsible for the complete coordination of multiple assigned human subjects’ (clinical) research projects and is expected to perform all core Clinical Research Coordinator (CRC) responsibilities. The Supervisor serves as a mentor, an educator, and a leader with first-line supervisory oversight (e.g., involved with hiring, reviewing, and terminating other associates). 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 Supervisor will be responsible for financial components of clinical research projects, documentation of investigator product (drug or device), development of source documents and/or case report forms and running research/project team meetings. In this role, the Supervisor may support investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, monitor or audit studies in the Research Institute, educate and mentor clinical staff, research team members, and other coordinators, and may be requested to coordinate multi-center studies. The Supervisor is responsible for evaluating CRC performance and assists the Site Manager in resolving operations workload, protocol implementation, and data collection issues. The Supervisor may also participate in one or more workgroups or committees within the Research Institute with a focus on CRC operations. The Supervisor is the most senior position in the Clinical Research Coordinator series.

Pay Range

Minimum $90,563 Midpoint $120,016 Maximum $149,427

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 six (6) years of clinical research coordination experience.
• Preferred: Clinical research experience in a hospital setting and/or pediatric clinical research experience and demonstrated leadership experience.

Education

• Required: Bachelor’s degree or equivalent additional experience can be accepted in lieu of education.
• Preferred: Master’s degree in a relevant field.

Specialized Skills

• Required: Working 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). Ability to conduct informed consent. Strong knowledge of research sample identification, processing, and storage. Ability to manage conflict and to create a culture of accountability within their assigned team. Demonstrate good time and priority management and is capable of problem-solving.
• Preferred: Working knowledge of Cerner or equivalent electronic medical record system.

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.
• Required: Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) - If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 12 months of assuming position. With management approval, the time in which to obtain certification may be extended past 12 months due to extenuating circumstances.
• Preferred: Phlebotomy certification.

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.