Clinical Research Coordinator
HDF Comprehensive Cancer Center Job Summary The Clinical Research Coordinator will be responsible for the coordination of the two following studies:
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by
establishing a multi-site cohort of individuals with increased risk for PDAC due to family history of PDAC
and/or individuals carrying pathogenic germline variants (PGVs) in genes linked to PDAC risk for
longitudinal follow up.
The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical
areas necessary for early detection and prevention of PDAC.
The Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH Study) is a multi-center comparative, prospective, cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri, a blood-based multi-cancer early detection (MCED) test.
The Galleri test screens for many of the deadliest cancers before they become symptomatic, including those without recommended screening tests.1,4 The test results provide a predicted Cancer Signal Origin to help your healthcare provider determine the next steps for diagnosis This study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).
This study is being conducted across the nation, in which UCSF will be one of the research sites. The study will enroll approximately 50,000 participants aged 50 and older with Medicare coverage who will receive Galleri in addition to usual care as well as a passively-enrolled contemporaneous comparator cohort of approximately 50,000 Medicare beneficiaries who receive usual care without MCED screening.
Continuing to work under the general supervision of the Principal Investigator and the Clinical Research Manager, the incumbent will be the Clinical Research Coordinator (CRC) for the Real world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH)Trial.
The CRC will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate the research protocol, as directed by the Clinical Research Manager and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency 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, 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, and assist Clinical Research Manager and/or PI with oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. 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. The salary range for this position is $34.32 - $55.19 (Hourly Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Department Description The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) holds the prestigious designation of "comprehensive" from the National Cancer Institute (NCI). We combine basic science, clinical research, epidemiology, cancer control and patient care throughout UCSF. 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.
- 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.
- 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.
Preferred Qualifications
- BA or BS in relevant field
- Bilingual
- Experience working with all regulatory aspects of clinical trials (including FDA, NCI, local IRB, and sponsor).
- Strong Project coordination skills and experience.
- 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.
- Experience with electronic data capture systems.
- Ability to work with a sensitive population of patients (oncology patients)
- Prior analytical and writing skills in a science/research environment
- Knowledge of clinical research in oncology
- Knowledge and experience in managing oncology clinical trials.
- Knowledge of medical terminology, research policies and guidelines, guidelines for packing / shipping infectious substances, database building / analysis, and data entry and management
- Knowledge of location specific and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the location's 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.)
- 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 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 at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide. Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Job Code and Payroll Title 009335 CLIN RSCH CRD Job Category Research and Scientific Bargaining Unit University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX) Location San Francisco, CA Campus Mission Bay (SF), Mount Zion (SF) Additional Shift Details Monday - Friday; Up to 5 days onsite. |
University of California - San Francisco Campus and Health
Nov 22, 2024