Clinical Research Coordinator - Early Phase Program

UCSF Health, AG; San Francisco (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

UCSF is seeking a Clinical Research Coordinator for the Early Phase program, focusing on investigational oncology trials. The CRC will oversee multiple protocols, coordinate administrative tasks, patient scheduling, and data management under supervision of the Clinical Research Manager and PI.

The role involves attending clinic visits, tracking test results, ordering study-related procedures, and ensuring adherence to federal, state, and local regulations.

Qualifications

• High School Degree or equivalent.
• Attention to detail; strong interpersonal skills; excellent verbal and written communication to coordinate with subjects, team members, departments and outside institutions; multi-task in a fast-paced environment.

Responsibilities

• Coordinate administrative, data, and patient scheduling operations for several concurrent studies.
• Maintain regulatory documents in partnership with the Regulatory department.
• Assist in study progress reporting to investigators and participate in audits.
• Support management and coordination of study procedures, tests, and data integrity.

Skills

Attention to detail

Interpersonal skills

Verbal and written communication

Multi-tasking

Able to work independently

Education

High School Degree

Tools

OnCore

Microsoft Office

Job description

Job Description

The Early Phase program has a multi-disciplinary team that works closely with patients, providing the resources and close cooperation of many specialists with deep expertise in diagnosing and treating early and late- stage cancer. Our physician-scientists are also researching and developing new and effective treatments for cancer, including clinical trials. The Early Phase program is seeking a Clinical Research Coordinator with an interest in investigational drugs to have oversight over multiple clinical research projects and support our growing program.

The Clinical Research Coordinator (CRC) will independently, or with general direction, execute, manage, and coordinate clinical research protocols, as directed by the Clinical Research Manager, Principal Investigator (PI), and/or the Associate Director of Clinical Research Programs for the Early Phase program. The CRC will coordinate the administrative, data, and patient scheduling operations of several concurrent clinical research studies under the guidelines of research protocols and regulatory policies. The CRC will assist in the care of early and late-stage cancer patients while they participate in phase 1 and phase 2 clinical trials. In the role, the CRC will attend clinic appointments, follow test results, and assist in ordering appropriate study-related procedures/tests. The CRC will have the opportunity to learn certain aspects of oncology including but not limited to prevention, early detection, treatment/medication management, and end of life care for cancer patients.

The duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies. This involves coordinating study required procedures and treatments for study patients; managing and updating databases to insure data integrity; acting as intermediary between sponsors, research staff, and various UCSF departments; assuring compliance with all relevant regulatory agencies; assisting Clinical Research Manager, Associate Director of Clinical Research Programs and/or PI with research tasks; maintaining relevant regulatory documents in partnership with the Regulatory department; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; and performing 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

• High School Degree
• 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Prior experience with various computer programs (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.
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting. Familiarity with specimen processing
• 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, 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 subjects
  • Effective Cash Handling Procedures
  • Environmental Health and Safety Training
  • Fire Safety Training

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as https://www.ucsf.edu/about/mission-and-values . In addition to , UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available https://diversity.ucsf.edu/ . Join us to find a rewarding career contributing to improving healthcare worldwide.

EEO Statement

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.