Senior Clinical Research Coordinator - Gastrointestinal Medical Oncology Program

University of California System•San Francisco, CA

25d•$42 - $67

About The Position

The Gastrointestinal Medical Oncology Program is a dynamic and growing multidisciplinary team focused on cancer research. Program members are involved in conducting translational research including studies authored by Program Investigators and collaborative research projects with multiple cancer centers, private companies in biotechnology, philanthropies and pharmaceutical industries. Under the general direction of the Program Leaders, the Senior Clinical Research Analyst will manage the Neuroendocrine Outcomes Database ("NET Database"), which is currently a growing database of over 2345+ patient cases. The Senior Clinical Research Analyst will: review eligibility of patient cases; abstract medical data; manage and conduct data entry and ensure quality of existing data; develop data collection and management processes, and; ensure compliance in data collection and sharing methods. The Senior Clinical Research Analyst will work to streamline the Oncore database in order to reduce data collection redundancies and improve quality assurance and quality control methods. S/He will work closely with Program Investigators, the UCSF Cancer Registry, the Pathology and Radiology departments, and other sources to review eligible patient cases, identify missed cases from past years, and add cases to the NET database at regular intervals. The Senior Clinical Research Analyst is also expected to assist in the interpretation of medical data in order to abstract the data for accurate reporting and statistical analysis. S/He will coordinate with internal and external collaborators at other institutions to share NET clinicopathologic data as described in IRB approved protocols. The Senior Clinical Research Analyst is expected to perform basic statistical analysis and literature reviews as well as work with Investigators to prepare scientific abstracts, manuscripts and presentations related to relevant research projects. S/He may be asked to lead clinical research meetings with collaborators to discuss relevant research projects. S/He is also expected to draft new protocols related to tissue banking and patient-reported outcomes and help to manage other regulatory matters related to relevant protocols. Duties may also include, but are not limited to: creating reports of data capturing progress; retrospective data mining and maintenance of an up- to-date database; analysis of comprehensive datasets; assurance of data integrity; 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 $41.72 - $67.10 (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

Requirements

Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
Ability to analyze complex and non-routine issues requiring innovative solutions.
Ability to operate effectively in a changing organizational and technological environment.
Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines.
Ability to interpret and apply policies and regulations.
Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
Experience using database software, such as MS Access or FileMaker Pro.
Coursework in basic statistical analysis required, preferably with emphasis on biostatistics.
Experience in clinical research data management with oncology cases.
Experience in medical record extraction. Demonstrated ability to interpret medical information, particularly for oncological data.
Experience in scientific writing. A scientific writing sample is required.
Experience using statistical analysis software (SAS, SPSS, STATA, R).
Experience in management of data quality assurance and quality control methods.
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.
Ability to relate effectively in person and via telephone and email with physicians, nurses, data managers, as well as medical records and information science departments.
Previous experience working with sensitive populations of patients, preferably cancer patients.
Ability to sit and work at a computer for up to 8 hours per Required day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
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

Nice To Haves

Masters degree in biological sciences, clinical research, public health, epidemiology/biostatistics or related.
Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
Advanced training in statistical analysis.
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 neuroendocrine malignancies.
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

Responsibilities

manage the Neuroendocrine Outcomes Database ("NET Database")
review eligibility of patient cases
abstract medical data
manage and conduct data entry and ensure quality of existing data
develop data collection and management processes
ensure compliance in data collection and sharing methods
streamline the Oncore database in order to reduce data collection redundancies and improve quality assurance and quality control methods
work closely with Program Investigators, the UCSF Cancer Registry, the Pathology and Radiology departments, and other sources to review eligible patient cases, identify missed cases from past years, and add cases to the NET database at regular intervals
assist in the interpretation of medical data in order to abstract the data for accurate reporting and statistical analysis
coordinate with internal and external collaborators at other institutions to share NET clinicopathologic data as described in IRB approved protocols
perform basic statistical analysis and literature reviews as well as work with Investigators to prepare scientific abstracts, manuscripts and presentations related to relevant research projects
lead clinical research meetings with collaborators to discuss relevant research projects
draft new protocols related to tissue banking and patient-reported outcomes and help to manage other regulatory matters related to relevant protocols
creating reports of data capturing progress
retrospective data mining and maintenance of an up- to-date database
analysis of comprehensive datasets
assurance of data integrity
other duties as assigned