Under the supervision of the Clinical Research Manager, 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 Clinical Trial manager 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 and IRB protocols. The CRC also supports the research team with additional duties as assigned (e.g., obtaining archived biospecimens or data for ongoing studies).
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 Supervisor 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 Supervisor 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; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; 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 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. Work Place: Requires fully On-Site during the first three months for training and afterwards requires On-Site 4 days a week with 1 day remote.
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
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 judgment in unexpected situations
Preferred Qualifications
Previous UC experience
4 years college graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols
Knowledge/experience with research regulatory processes
Knowledge/experience with REDCap database and OnCore
Knowledge/experience in submitting protocols to Institutional Review Board (IRB or CHR)
Understanding of patient populations to build rapport and assess appropriate participation
Experience with EPIC medical record system or other electronic medical records
Knowledge of UCSF and departmental policies including reimbursement, research guidelines, confidentiality and HIPAA regulations, patient safety, and handling of medical records; familiarity with medical terminology, database tools (Access, Stata, SAS/SPSS, Teleform), and data management
Experience applying the following regulations and guidelines:
Good Clinical Practice (GCP) Guidelines
Health Insurance Portability and Accountability Act (HIPAA)
Protection of Human Research Subjects
CHR regulations for recruitment and consent
Effective Cash Handling Procedures
Environmental Health and Safety Training
Fire Safety Training
60% Protocol Management: Protocol management is an ongoing activity throughout the period of the trial.
Studies open to enrollment: Assist physicians in screening and checking eligibility for potential candidates for the clinical trials using multiple hard copy and electronic databases including REDCap, APEX, clinical notes, and medical records; Initiates first contact with potential study candidate to introduce possible, appropriate clinical trial; Consents study participants; Registers participants to appropriate registration system; Maintains patient tracking forms, reporting and recording adverse events, and collection of correlative specimens as required. The CRC must coordinate activities with multiple departments, i.e., Infusion center, lab or radiology, as well as coordinate protocol recruitment and correlative specimen collection with non-UCSF sites, and schedule tests. Problems in either of these areas will lead to failed trials or put study subjects in jeopardy.
Studies with Follow-up: The CRC must create follow-up tracking forms, maintain protocol reports, record data points in electronic databases, assist the Principal Investigator with publication, data analysis, and coordinate drug accountability with the sponsoring company. There can be several protocols requiring follow-up protocol management.
35% Data Management: Data and biospecimen collection and management for clinical trials and population studies in the Department of Urology involving prostate, renal, and bladder cancer for departmentally managed clinical trials and study registries. Abstract, manage, and maintain records on multiple databases which track clinical outcomes of patients being treated for urologic health. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms (CRFs), study flow sheets, multiple electronic databases and other required study forms for specific protocols.
5% A Member of the CRC Team: The CRC is a team-player participating in assignments needed by the Department of Urology which can include filing and weekly team meetings aimed at communication and development of policy and procedures. Other duties as assigned
60% Protocol Management: Protocol management is an ongoing activity throughout the period of the trial.
Studies open to enrollment: Assist physicians in screening and checking eligibility for potential candidates for the clinical trials using multiple hard copy and electronic databases including REDCap, APEX, clinical notes, and medical records; Initiates first contact with potential study candidate to introduce possible, appropriate clinical trial; Consents study participants; Registers participants to appropriate registration system; Maintains patient tracking forms, reporting and recording adverse events, and collection of correlative specimens as required. The CRC must coordinate activities with multiple departments, i.e., Infusion center, lab or radiology, as well as coordinate protocol recruitment and correlative specimen collection with non-UCSF sites, and schedule tests. Problems in either of these areas will lead to failed trials or put study subjects in jeopardy.
Studies with Follow-up: The CRC must create follow-up tracking forms, maintain protocol reports, record data points in electronic databases, assist the Principal Investigator with publication, data analysis, and coordinate drug accountability with the sponsoring company. There can be several protocols requiring follow-up protocol management.
35% Data Management: Data and biospecimen collection and management for clinical trials and population studies in the Department of Urology involving prostate, renal, and bladder cancer for departmentally managed clinical trials and study registries. Abstract, manage, and maintain records on multiple databases which track clinical outcomes of patients being treated for urologic health. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms (CRFs), study flow sheets, multiple electronic databases and other required study forms for specific protocols.
5% A Member of the CRC Team: The CRC is a team-player participating in assignments needed by the Department of Urology which can include filing and weekly team meetings aimed at communication and development of policy and procedures. Other duties as assigned