Clinical Research Coordinator - Pediatric Gastroenterology (Oakland)

University of California, San Francisco; Oakland (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

University of California, San Francisco (UCSF) Benioff Children’s Hospital Oakland seeks a Clinical Research Coordinator to execute, manage, and coordinate pediatric research protocols under supervision. You will enroll patients, manage data and biospecimens, and ensure regulatory compliance across multiple studies.

The role involves interacting with investigators, coordinating with departments, and maintaining study documentation while supporting quality control and audits.

Qualifications

• High School Diploma or equivalent.
• Excellent verbal and written communication and presentation skills.
• Attention to detail and strong organizational and interpersonal skills.
• Ability to multi-task in a fast-paced environment and coordinate with diverse teams.
• Proficiency with Microsoft Word, PowerPoint, and Windows.

Responsibilities

• Enrol patients in clinical studies and manage data entry.
• Coordinate biospecimen collection and processing.
• Attend and document proceedings at meetings and prepare regulatory documents.
• Complete IRB applications, revisions, and reports.
• Maintain regulatory documents and assist with audits or reviews.

Skills

Verbal communication

Written communication

Attention to detail

Multi-tasking

Organization

Interpersonal skills

Project management

Education

High School Diploma

Tools

Microsoft Word

PowerPoint

Windows

Job description

The location of this position is Benioff Children's Hospital in Oakland, CA**

Job Description

The Clinical Research Coordinator (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. This position will operate in one or more divisions within the Department of Pediatrics and will likely support multiple investigators. Assignments may change based on funding availability. May coordinate the operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The position’s duties include enrolling patients in clinical studies, data entry and management, biospecimen collection and processing, attending and documenting proceedings at relevant meetings, preparing grant proposals and reports, completing regulatory documents, Institutional Review Board applications, revisions and reports, and other duties as assigned.

CRC 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 the 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 Institutional Review Board 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

The Department of Pediatrics is one of the largest and most complex departments in the School of Medicine (SOM). The Department is comprised of 18 divisions employing over 400 core faculty, 83 fellows, 84 residents, 31 Post Docs and non-faculty academics, and 300 staffs. The Department has annual clinical income from inpatient and outpatient activities totaling over $100 million and annual extramural funding (contracts and grants) exceeding $58 million. The Department ranks 21st in the nation among pediatric departments for funding from the National Institutes of Health (NIH).

The Department’s clinical enterprise is based at the 183-bed UCSF Benioff Children’s Hospital San Francisco, the 191-bed UCSF Benioff Children’s Hospital Oakland, Mount Zion, Zuckerberg San Francisco General, and at a number of outreach clinics throughout Northern California, providing the Department with an unsurpassed opportunity to meet the needs of infants, children, and young adults throughout the Bay Area. In 2020, UCSF Benioff Children’s Hospitals ranked in all 10 children’s specialties in U.S. News and World Report.

Qualifications

• High School Diploma; or equivalent experience/training
• Excellent verbal and written communications and presentation skills ; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Attention to details; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions and companies; and the ability to multi-task in a fast-paced environment while working with a diverse subject population
• Proficiency with Microsoft Word, PowerPoint, and Windows
• Excellent analytical and problem-solving skills
• Ability to work well independently and complete projects in a timely manner; in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects
• Ability to establish cooperative working relationships with patients, co-workers, & physicians

Preferred Qualifications

• Demonstrate proficiency with medical terminology
• Experience working with patients or study subjects
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
• 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 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
• Knowledge of UCSF guidelines for research, confidentiality and Health Information and Accountability Act (HIPAA) regulations, following the UCSF mission statement and purpose for research, and clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
• Experience applying the following regulations and guidelines:
  • Good Clinical Practice Guidelines
  • HIPAA
  • The Protection of Human Research Subjects