Clinical Research Coordinator - Pediatrics Research

University of California, San Francisco; San Francisco (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

University of California, San Francisco in San Francisco, CA is seeking a Clinical Research Coordinator to independently execute and coordinate pediatric research protocols under supervision. The role involves data collection, study management, and ensuring regulatory compliance across multiple concurrent studies, in collaboration with the Clinical Research Supervisor and PI.

Responsibilities include maintaining regulatory documents, preparing databases and reports, coordinating staff schedules,

Qualifications

• High School Diploma or equivalent; ability to complete tasks accurately.
• Excellent interpersonal and written communication skills for coordinating with teams and study subjects.
• Ability to multi-task in a fast-paced clinical research environment.

Responsibilities

• Coordinate data collection and operations across multiple clinical studies.
• Manage regulatory documents and IRB submissions under supervision.
• Prepare databases, reports, and study progress updates for investigators.
• Ensure compliance with GCP, HIPAA, and CHR regulations.

Skills

Attention to detail

Interpersonal communication

Multi-tasking

Education

High School Diploma or equivalent experience

BA/BS degree with biology coursework included

Job description

Job Description

TheClinicalResearchCoordinator(CRC) 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) in the Department of Pediatrics; may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Job Description

TheClinicalResearchCoordinator(CRC) 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) in the Department of Pediatrics; may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The CRC’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 and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Institutional Review Board (IRB) 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.

Qualifications

• High School Diploma; or equivalent experience
• 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

• Fluent in Spanish
• BA/BS degree with biology coursework included
• Two years experience in a clinical research setting
• 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
• Experience with electronic medical records
• Knowledge of medical terminology, and/or the ability to apply information to the assessment, interpretation, and processing of medical data
• 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