|
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. Incumbent's 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.
% of time (Nothing less than 5%) |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
10% |
Yes |
Research Operations Management:
- Develop project plans, interview key sponsors, and deliver tangible project results
- Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
- Design and perform ad-hoc performance analysis of the projects and the project staff
- Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects
- Perform business process review, operational reviews and design and implement workflow and controls
- Develop project-related presentation material for study
- Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
|
50% |
Yes |
Clinical Trials Management:
- Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
- Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date.
- Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors.
- Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner.
- Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
|
5% |
Yes |
Longitudinal Cohort Studies:
- Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution of studies.
- Manage activities for cohorts in various areas of studies and disciplines; and for clinical trials in various disciplines.
- Collaborate with other Universities, clinical entities, and industry using collected data to understand disease progression and predictors.
- May contribute to or lead scientific presentations and publications based on study data collected.
- May contribute to the development of new grant proposals.
|
5% |
|
Risk Management:
- Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success.
- Act as regulatory authority and advisor by training and educating employees and advising leadership and PI's.
- Manage audits.
- Help institute and maintain a Quality Improvement Process.
|
5% |
Yes |
Financial Management:
- Oversee budgets, invoices, and reimbursements.
- Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients.
- Guide subjects through financial process (private vs. federal trials and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible
- Review budget reports on a monthly basis.
Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds. Responsible for ensuring that the use of research funding is in compliance with funding agency protocols. Assist PI in grant development, focusing on budget development. |
25% |
Yes |
HR Management/Administration:
Recruit and train clinical research coordinators in collaboration with leadership. Mentor clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry. Train in federal and local research laws and guidelines. Help manage personnel needs. |
100% |
|
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) |
Required Qualifications:
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
- 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:
- 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.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- 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. - 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.
- 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 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 Required Qualifications:
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
- 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:
- 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.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- 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. - 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.
- 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 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
|
University of California - San Francisco
$38.23 - $44.81
May 05, 2026