Clinical Research Coordinator - Genitourinary Oncology Program

UCSF Health, AG; San Francisco (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

UCSF Health is seeking a Clinical Research Coordinator to independently manage and coordinate research protocols within the Genitourinary Oncology Program at UCSF. The role includes data collection, regulatory compliance, and cooperation with the PI and Research Personnel Manager to ensure high-quality studies.

The ideal candidate will have clinical research experience, familiarity with OnCore, and strong communication skills, with the ability to work across departments and mentor CRC staff.

Qualifications

• High School Diploma; or equivalent experience.
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting. Familiarity with specimen processing.
• Experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical 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 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
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
• 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
• Ability to apply relevant information to the assessment, 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
• Ability to work with a sensitive population of patients (oncology patients)
• Pref Qualifications: Prior analytical and writing skills in a science/research environment
• Pref Qualifications: Experience with electronic medical records
• Pref Qualifications: Knowledge of UCSF policies for research, HIPAA, and patient safety

Responsibilities

• Coordinate the data collection and operations of several concurrent clinical research studies under the guidance of the Lead CRC, PI, and/or Research Personnel Manager.
• Oversee data and specimen management; report study results and maintain comprehensive datasets and reports.
• Train and supervise Assistant CRCs and other CRC team members; assist with oversight of other research staff.
• Ensure compliance with applicable regulatory agencies; participate in audits and reviews of study protocols.
• Interface with departments to obtain approvals prior to study initiation; maintain regulatory documents with the Regulatory department.
• Maintain data integrity and perform quality control procedures; support staff scheduling and workload management.
• Assist with budgeting, project planning, and communicating study progress to investigators.

Skills

Attention to detail

Communication skills

Independent work

Data management

Education

High School Diploma

Tools

OnCore

Microsoft Office

Job description

Description & Requirements

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 Lead Clinical Research Coordinator, Principal Investigator (PI), and/or the Research Personnel Manager for the Investigational Trials Unit, specifically for Genitourinary Oncology Program; 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, assist with training of Assistant CRCs and other CRC team members, and assist Research Personnel Manager and/or PI with oversight of other research staff; 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 relevant regulatory documents in partnership with the Regulatory department; 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 UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the prestigious designation of "comprehensive" from the National Cancer Institute. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical trials across various departments.

Qualifications

Required Qualifications:

• High School Diploma; or equivalent experience
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting. Familiarity with specimen processing
• Experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical 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 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
• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
• 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
• Ability to apply relevant information to the assessment, 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
• Ability to work with a sensitive population of patients (oncology patients)

Preferred Qualifications:

• Prior analytical and writing skills in a science/research environment
• 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, 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
• Knowledge of clinical research in breast oncology
• Knowledge and experience in managing oncology clinical trials
• Membership in a clinical research professional society
• 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 subjectsEffective Cash Handling Procedures
• Environmental Health and Safety Training
• Fire Safety Training