Clinical Research Coordinator - Urology

University of California San Francisco•San Francisco, CA

13d•$34 - $55

About The Position

Under the supervision of the Clinical Research Director, Clinical Research Coordinators (CRC) support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed. Responsibilities include communicating with the Director to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI. The CRC will support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures. Independently, the CRC maintains protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study. The CRC supports the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies. The CRC also supports the research team with additional duties as assigned. The Department of Urology in the School of Medicine educates medical students, residents, and clinical and postdoctoral fellows in urology; conducts basic science, clinical, and epidemiological research, including clinical trials; and provides professional patient care services. The Department conducts its teaching, research, and patient care activities at five major sites: the Parnassus campus, Mission Bay, San Francisco General Hospital (SFGH), the San Francisco Veterans Administration Medical Center (SFVAMC), and the UCSF Benioff Children’s Hospital Oakland. 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 Clinical Research Director 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. The 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, assist with training of Assistant CRCs, and assist Clinical Research Director and/or PI with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; 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

Requirements

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
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.
Possess moderate to high degree of database skills
Detailed oriented, and accurate
Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting PIs for multiple departments.
Outstanding communication skills
Ability to learn new tasks quickly and apply good judgement in unexpected situation
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 internal review board protocol and renewal process
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 in various platforms
Experience applying the following regulations and guidelines: Good Clinical Practice (GCP), Health Information and Accountability Act (HIPAA), Protection of human research subjects, CHR regulations for recruitment and consent of research subjects, Environmental Health and Safety Training, Equal Employment Opportunity

Nice To Haves

Previous UC experience
Experience with REDCap, LIMS, Oncore

Responsibilities

Support the clinical trial management of investigator-sponsored, pharmaceutical-sponsored, and/or other types of consortium trials programs as assigned/needed.
Communicate with the Director to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval, and report study progress to the appropriate PI.
Support 2-3 active studies and 1-2 follow-up studies, depending on the complexity of the patients and procedures.
Maintain protocol files, data collection and subject source records, develops project management documents and electronic data forms for each assigned study.
Support the investigator in research study project management to assure compliance with the Code of Federal Regulations and the ICH Guidance on Good Clinical (Research) Practice as well as UCSF Institutional policies.
Support the research team with additional duties as assigned.
Execute, manage, and coordinate research protocols, as directed by the Clinical Research Director and/or Principal Investigator (PI).
Coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
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, assist with training of Assistant CRCs, and assist Clinical Research Director and/or PI with oversight of other research staff.
Manage Investigator’s protocols in the Committee on Human Research online system.
Oversee study data integrity.
Implement and maintain periodic quality control procedures.
Interface with departments to obtain UCSF approval prior to study initiation.
Maintain all regulatory documents.
Report study progress to investigators.
Participate in any internal and external audits or reviews of study protocols.
Perform other duties as assigned.