Supervisor, Clinical Research Coordinator, Neonatology

CHOC•Orange, CA

26d•$90,563 - $149,427•Onsite

About The Position

The Clinical Research Coordinator Supervisor (CRC-Su) independently coordinates multiple assigned human-subjects clinical research projects and performs all core Clinical Research Coordinator responsibilities. The Supervisor serves as a mentor, educator, and leader with first-line supervisory oversight, including involvement in hiring, reviewing, and terminating associates. This is the most senior position in the Clinical Research Coordinator series. Study management includes assessing protocol feasibility; preparing materials for regulatory review and Institutional Review Board (IRB) submissions; identifying potential study participants; coordinating and collecting research data and specimens; maintaining accurate, timely study records; participating in quality assurance audits; managing study materials and supplies; communicating across teams; and archiving records according to applicable policies and procedures. The Supervisor is responsible for project financial components, investigator product documentation, developing source documents and/or case report forms, and conducting research/project team meetings. The role 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 and research team members, and coordinate multi-center studies. The Supervisor evaluates CRC performance and assists the Site Manager with workload, protocol implementation, and data collection issues. The role may also participate in Research Institute workgroups or committees focused on CRC operations.

Requirements

At least six years of clinical research coordination experience.
Bachelor’s degree, or equivalent additional experience in lieu of education.
Working knowledge of Microsoft Office programs, including Word, Excel, and PowerPoint.
Strong interpersonal skills and effective oral and written communication skills.
Attention to detail and ability to work under pressure in a fast-paced environment while managing competing priorities.
Working knowledge of human-subjects regulatory requirements and ICH-GCP guidelines.
Ability to conduct informed consent.
Strong knowledge of research sample identification, processing, and storage.
Ability to manage conflict and create a culture of accountability within the assigned team.
Good time and priority management and problem-solving skills.
Basic Life Support (BLS) certification from the American Heart Association; if not held at hire or promotion, certification is expected within six months, subject to possible extension with management approval.
ACRP-CP, CCRP, or CCRC certification; if not held at hire or promotion, certification is expected within 12 months, subject to possible extension with management approval.

Nice To Haves

Clinical research experience in a hospital setting and/or pediatric clinical research experience.
Demonstrated leadership experience.
Master’s degree in a relevant field.
Working knowledge of Cerner or an equivalent electronic medical record system.
Phlebotomy certification.

Responsibilities

Independently coordinate multiple assigned human-subjects clinical research projects and perform core Clinical Research Coordinator responsibilities.
Mentor, educate, and lead associates, with first-line supervisory oversight that may include hiring, reviewing, and terminating associates.
Assess clinical research protocol feasibility and prepare materials for regulatory review and IRB submission.
Identify potential study participants and coordinate the collection of research data and specimens.
Complete study records accurately and in a timely manner; participate in quality assurance audits; manage study materials and supplies; and archive records according to applicable policies and procedures.
Manage financial components of clinical research projects and document investigator products, including drugs or devices.
Develop source documents and/or case report forms and conduct research/project team meetings.
May support investigator-initiated IND or IDE applications, monitor or audit Research Institute studies, and coordinate multi-center studies.
Educate and mentor clinical staff, research team members, and other coordinators.
Evaluate CRC performance and assist the Site Manager in resolving workload, protocol implementation, and data collection issues.
May participate in Research Institute workgroups or committees focused on CRC operations.