Supervisor Clinical Research Coordinator (Orthopedics)

Children's Hospital of Orange County • Orange, CA

1d • Onsite

About The Position

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.

Requirements

• Minimum six (6) years of clinical research coordination experience.
• 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.
• Basic Life Support (BLS) - American Heart Association certification expected within 6 months of assuming position (may be extended with management approval).
• Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification expected within 12 months of assuming position (may be extended 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 equivalent electronic medical record system.
• Phlebotomy certification.

Responsibilities

• Functions independently and is responsible for the complete coordination of multiple assigned human subjects’ (clinical) research projects.
• Performs all core Clinical Research Coordinator (CRC) responsibilities.
• Serves as a mentor, an educator, and a leader with first-line supervisory oversight (e.g., involved with hiring, reviewing, and terminating other associates).
• Assesses feasibility of clinical research protocols.
• Prepares materials needed for regulatory review and submission to the Institutional Review Board (IRB).
• Identifies potential study participants.
• Coordinates and collects research data/specimens.
• Completes study records in an accurate and timely manner.
• Participates in quality assurance audits.
• Manages study materials and supplies.
• Communicates across multiple teams.
• Archives records in accordance with appropriate policies and procedures.
• Responsible for financial components of clinical research projects.
• Responsible for documentation of investigator product (drug or device).
• Develops source documents and/or case report forms.
• Runs research/project team meetings.
• May support investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.
• May monitor or audit studies in the Research Institute.
• Educates and mentors clinical staff, research team members, and other coordinators.
• May be requested to coordinate multi-center studies.
• Responsible for evaluating CRC performance.
• Assists the Site Manager in resolving operations workload, protocol implementation, and data collection issues.
• May participate in one or more workgroups or committees within the Research Institute with a focus on CRC operations.

Benefits

• CHOC’s compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior