The Pediatric Neuro-Oncology Consortium (PNOC) currently seeks a Clinical Research Coordinator (CRC) ideally with prior experience in clinical research to join the Operations Office and assist the Data Team Lead, Project Managers and Operations Manager in data management and quality oversight, overseeing regulatory documents and submissions, participant registration, and other special projects as needed. The PNOC CRC will work under supervision from the Data Team lead and become part of the Operations Office of PNOC. The PNOC CRC will be asked to work flexibly and cooperatively within the framework of the consortium in order to contribute to the overall success of the operation. Candidates with prior knowledge of ethics committee (IRB) submissions as well as patient, data, consenting, and regulatory document management within a clinical research trial will be given priority due to the need to work closely with, and understand the needs of, investigators and coordinators across multiple sites. We are a team dedicated to learning and improvement and welcome those who are proactive learners and creative communicators.

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 Data Team Lead, Project Manager(s) and/or Operations Manager; may coordinate the data review and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. This CRC position may interface with patients and support the PNOC Operations Office staff in administrative, data, and quality functions.

PEDIATRIC NEURO-ONCOLOGY CONSORTIUM
The Pediatric Neuro-Oncology Consortium (PNOC) was founded in 2012 in response to the growing need for innovative research in children/young adults with brain cancer. The consortium is a collaborative effort between nineteen domestic institutions as well as international institutions in Europe, Australia, Canada, and India. The Operations Office for PNOC provides leadership and manages the infrastructure of the consortium and is nested under the UCSF Department of Neurology and Department of Neurosurgery.

% of time (Nothing less than 5%)	Essential Function (Yes/No)	Key Responsibilities (To be completed by Supervisor)
25	YES	Data management and reporting of results Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Create and maintain comprehensive data sets as requested by the Data Team Lead Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analysis in databases. Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
5	YES	Staff training Create training material including guidelines and training videos Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures. Attend and actively participate in regular team meetings Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures Consent participants onto PNOC studies Administer computerized neurocognitive testing to participants Organize PNOC quality of life data collection efforts Register participants into database Work with member institutions to review, approve, and submit study documents to their site IRB Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments
10	YES	Quality control procedures
25	YES	Study Implementation Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies. Modify data collection instruments Help schedule staff time and coordinate staff schedules. Maintain subject tracking systems.
25	YES	Protocol Submissions and Adherence Enter all existing and new study protocols into the IRB online system; seek assistance on maintaining all protocols in the system by communicating with IRB Analysts. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality. Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance. Renew, modify, and submit IRB applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators. Provide quality assurance checks to note if protocols or UCSF IRB applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
10	YES	Regulatory responsibilities Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Initiate and follow-up on IRB submissions and modifications; track approval status. Interface with departments to obtain UCSF approval prior to study initiation. Maintain regulatory documents; monitor timelines for data submission Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

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.
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment.
Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
Experience with various computer programs (Microsoft Office, etc.)

Preferred Qualifications:

Experience with electronic medical records.
Prior analytical and writing skills in a science/research environment
Knowledge of guidelines for research, confidentiality and HIPAA 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: Salesforce, 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

IRB regulations for recruitment and consent of research subjects

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 our PRIDE values.

In addition to our PRIDE values, 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 here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

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.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Clinical Research Coordinator

Job Description

Data management and reporting of results

Study Implementation

Regulatory responsibilities

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