Clinical Research Coordinator – Melanoma and Cutaneous Oncology Program

Job Description

Job Summary:

The Cutaneous Oncology clinical research team supports a diverse portfolio of studies for melanoma and non-melanoma skin cancers, including squamous cell, basal cell, and Merkel cell carcinomas. The team partners with specialists across Dermatology, Medical Oncology, Surgical Oncology, and Radiation Oncology to provide comprehensive, multidisciplinary care. Our focus includes outpatient, therapeutic cancer clinical trials in phases I–III, including both industry-sponsored and investigator-initiated studies. We also manage noninterventional studies aimed at improving early detection, risk assessment, and long-term survivorship.

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.

Duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies; managing and updating databases to ensure data integrity; acting as intermediary between sponsors, research staff, and various UCSF departments; help assure compliance with all relevant regulatory agencies;; 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 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
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

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
Demonstrated knowledge and understanding of research, especially in the areas of biological sciences
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 research or training experience that translates into a clinical research setting
Familiarity with specimen processing, or demonstrated ability to learn specimen processing in a laboratory environment
Working knowledge of, or demonstrated ability to learn federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
Knowledge of medical terminology, and/or the ability to apply 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)
Ability to work across several different programs, reporting to 2-3 different supervisors
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