Clinical Research Coordinator - Cancer Center (Berkeley/Burlingame)

University of California, San Francisco; Berkeley (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

University of California, San Francisco's Helen Diller Family Comprehensive Cancer Center seeks a Clinical Research Coordinator to support clinical research programs at partner sites, including Berkeley and Burlingame locations. The CRC will coordinate protocols and data under the supervision of the CRM, Operations Manager, and PI, handling data collection, study management, and regulatory matters.

The role requires strong communication, meticulous attention to detail, and the ability to manage

Qualifications

• Experience in clinical research or related training translating to a clinical setting.
• Strong attention to detail and excellent written/verbal communication.
• Ability to multitask and coordinate with multiple departments and external sites.
• Knowledge of federal, state, and local research regulations and HIPAA guidelines.
• Experience using regulatory databases and regulatory document management.

Responsibilities

• Coordinate multiple clinical studies, data collection, and regulatory documentation.
• Interact with investigators, CRM, and PI to ensure protocol compliance and timelines.
• Manage study data integrity, audits, and regulatory submissions; maintain IRB records.
• Prepare, clean, and maintain databases and comprehensive datasets and reports.
• Support site coordinators and travel between UCSF locations as needed.

Skills

Clinical Research

Regulatory Compliance

IRB Systems

Data Management

Communication

Education

High School Diploma

Tools

OnCore

Microsoft Office

Access

Stata

SAS

SPSS

Teleform

Job description

Job Description

Job Summary:

• This position requires flexibility to work across various UCSF Medical Center locations, including UCSF Cancer Center in Berkeley and Burlingame.**

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Network Office is seeking a Clinical Research Coordinator (CRC) to support the clinical research programs at our UCSF partner sites. The 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 Manager (CRM), Operations Manager, 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.

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 CRM and/or PI with oversight of other research staff; manage Investigator’s protocols in the Institutional Review Board online systems, 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 Summary

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI).

The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Qualifications

Required Qualifications:

• High School Diploma; or equivalent experience
• Experience in clinical research or demonstrated research or training experience that translates into a clinical research setting
• 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 multitask 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
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
• Experience with various computer program (Microsoft Office; internet-based databases) and using specialized software such as OnCore
• Ability to sit and work at a computer for several hours per day; may need to travel between one or more campuses via UCSF shuttle; ability to stand for several hours of the day
• Working knowledge of federal, state, and local research; regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Ability to apply relevant information to the assessment, required interpretation, and processing of medical data
• Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environment

Preferred Qualifications

• Fluency in the usage of IRB online system, iRIS, 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 location specific 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
• Ability to work with a sensitive population of patients (oncology patients)
• Prior analytical and writing skills in a science/research environment
• Knowledge of clinical research in oncology
• Knowledge and experience in managing oncology clinical trials
• Membership in a clinical research professional society
• 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