Clinical Research Coordinator - Pediatric Critical Care

UCSF Health, AG; San Francisco (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

UCSF Health, AG is seeking a Clinical Research Coordinator to independently manage and coordinate research protocols in the Pediatric Critical Care group. You will oversee data collection, specimen management, and reporting of study results under the guidance of the Clinical Research Supervisor and Principal Investigator.

You will help maintain regulatory documents, coordinate staff schedules, and assist with protocol submissions and audits, ensuring compliance with UCSF policies and CHR/HIPAA

Qualifications

• High School Diploma or equivalent.
• Detail-oriented with strong interpersonal and communication skills.
• Ability to multi-task in a fast-paced environment.

Responsibilities

• Execute, manage, and coordinate clinical research protocols under supervision.
• Coordinate data collection and operations for multiple studies.
• Manage study data integrity and reporting to investigators.
• Assist with protocol submissions, renewals, and regulatory documents.
• Support training and oversight of junior staff and interns.
• Interface with departments to ensure approvals and compliance.

Skills

Attention to detail

Interpersonal skills

Verbal and written communication

Multitasking

Independent work

Education

High School Diploma

Bachelor's degree in related area

Tools

iMEDris

EMR systems

Job description

Job Summary

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Department Overview

This CRC position will work closely with the UCSF Pediatric Critical Care Clinical Research Group https://pc3rg.ucsf.edu/. The PC3RG is a team of physicians in the Department of Pediatrics, Division of Critical Care Medicine that practices medicine in the Pediatric Intensive Care Units of UCSF Benioff Children's Hospital at both the San Francisco and Oakland campuses. We staff over 60 pediatric critical care beds and treat a variety of diseases ranging from pneumonia, sepsis, trauma, and multi-organ failure in patients ranging from newborn to over 21 years old with baseline health ranging from healthy to complex medical conditions like cancer and congenital heart disease. Our team maintains a portfolio of 10-15 active studies including interventional clinical trials that test new therapies and observational studies that collect clinical data and research biospecimens to generate new scientific knowledge. At UCSF, we believe that sick children should have access to the most cutting edge medical care and should also have the opportunity to participate in research and contribute to new discoveries.

Qualifications

Required Qualifications

• High School Diploma; or equivalent experience/training
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

Preferred Qualifications

• Bachelor's degree in related area; or equivalent experience/training
• Bilingual Spanish/English speaker with experience communicating in Spanish with monolingual families over participation in clinical research.
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with electronic medical records
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
• Experience applying the following regulations and guidelines:

• - Good Clinical Practice Guidelines
• - Health Information and Accountability Act (HIPAA)
• - The Protection of Human Research Subjects
• - CHR regulations for recruitment and consent of research subjects
• - Effective Cash Handling Procedures
• - Environmental Health and Safety Training
• - Fire Safety Training