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The University of California San Francisco is seeking applications for the Clinical Research Coordinator (CRC) to join the Traumatic Brain Injury (TBI) research team. Within the Department of Neurological Surgery, the Brain and Spinal Injury Center (BASIC) is a large clinical and research division with over 40 physicians, nurses, research faculty, staff and trainees at the ZSFG Hospital campus. Many colleagues from other departments, other universities throughout the US, and other countries form an active group of investigators and staff with whom we collaborate. The incumbent will serve as a member of the BASIC TBI clinical research team. The CRC 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 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 CRC duties may include, but will not be limited to, supporting the management and coordinating the tasks of single or multiple clinical research studies, both industry and federally funded. Duties may include screening and enrolling study subjects, scheduling subjects for study visits, administering questionnaires, collecting medical history and performing study procedures. Coordination of studies will require the CRC to act as intermediary between services and departments (e.g., neurosurgery, neurology, pharmacy, radiology) while overseeing data and specimen management; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, and assist the Research Supervisor at BASIC and/or PI with training and oversight of other research staff; manage Investigator's protocols in the Committee on Human Research online system; help assure compliance with all relevant regulatory agencies; oversee study data integrity; 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.
10 |
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.
- Assists in the development and maintenance of departmental Standard Operating Procedures (SOPs)
- Designs, implements, and manages systems for organizing, planning, and maintaining efficient workflow related to all clinical research activities
- Initiates a clinical trial study. Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment. Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety.
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15 |
Yes |
Data Management and Reporting of Results
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- Respond to sponsor queries.
- 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 Supervisor and/or PI.
- 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.
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50 |
Yes |
Study Coordination and Data Collection:
- Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
- Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
- Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
- Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
- Oversee subject reimbursement; work to resolve discrepancies and issues.
- Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
- Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
- Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
- Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
- Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
- Maintain data collection forms for effective data collection, entry, and analysis.
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5 |
Yes |
Staff training:
- 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.
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10 |
Yes |
Regulatory Documentation
- Works with Principal Investigators to prepare/edit protocols for initial submission to local IRB in accordance with FDA regulations and Good Clinical Practice (GCP)
- Submits protocols to appropriate committees according to local policy
- Sets up and maintains files of all regulatory documents including adverse events documentation
- Prepares for and coordinates external audit visits by sponsors and regulatory agencies and prepares documents required by external auditors
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10 |
Yes |
Specimen Management/Maintenance
- Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
- Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
- Ensure integrity and security of samples.
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100% |
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Required Qualifications:
- High School Diploma; and/or equivalent experience/training
- Experience with administering patient reported outcome measures and standardized assessments
- Experience with data abstraction and data entry
- Excellent computer skills and demonstrated proficiency working with Microsoft Word, Excel, Access, and PowerPoint
- 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
- Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion
- Advanced interpersonal skills, judgment, and diplomacy when communicating with staff and faculty at different levels of an organization; ability to work with diverse groups including physicians, researchers, faculty, fellows, students, nurses, and support staff. A proven ability to interact and effectively influence within a dynamic organization
- Proven ability to be self-motivated and perform effectively under the pressure of deadlines and multiple competing projects. 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
- Must be a team-player, participating in assignments and taking on tasks of coworkers as needed by the group, which includes participating in weekly team meetings, juggling competing priorities of individually assigned studies and those of the research team as a whole, and communication/development of best clinical practice procedures within the team
Preferred Qualifications:
BA/BS with a major in a related field, including two years of experience in clinical research experience with coordination of neurological/neurosurgical human subjects research studies Experience with electronic medical records Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation Knowledge of medical terminology, and the ability to apply it to the assessment, interpretation, and processing of medical data Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion 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 within some of the following: Access, Stata, SASS/ SPSS, and SQL Fluency in the usage of Committee of Human Research (CHR) IRB-iRIS (formerly iMedRIS) for submission, renewal, and modification of protocols through this system Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals 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
Required Qualifications:
- High School Diploma; and/or equivalent experience/training
- Experience with administering patient reported outcome measures and standardized assessments
- Experience with data abstraction and data entry
- Excellent computer skills and demonstrated proficiency working with Microsoft Word, Excel, Access, and PowerPoint
- 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
- Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion
- Advanced interpersonal skills, judgment, and diplomacy when communicating with staff and faculty at different levels of an organization; ability to work with diverse groups including physicians, researchers, faculty, fellows, students, nurses, and support staff. A proven ability to interact and effectively influence within a dynamic organization
- Proven ability to be self-motivated and perform effectively under the pressure of deadlines and multiple competing projects. 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
- Must be a team-player, participating in assignments and taking on tasks of coworkers as needed by the group, which includes participating in weekly team meetings, juggling competing priorities of individually assigned studies and those of the research team as a whole, and communication/development of best clinical practice procedures within the team
Preferred Qualifications:
BA/BS with a major in a related field, including two years of experience in clinical research experience with coordination of neurological/neurosurgical human subjects research studies Experience with electronic medical records Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation Knowledge of medical terminology, and the ability to apply it to the assessment, interpretation, and processing of medical data Excellent analytic and organizational skills, and an ability to operate independently, prioritize, and create detailed timelines and schedules for several different tasks, managing each task from beginning to completion 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 within some of the following: Access, Stata, SASS/ SPSS, and SQL Fluency in the usage of Committee of Human Research (CHR) IRB-iRIS (formerly iMedRIS) for submission, renewal, and modification of protocols through this system Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals 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
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University of California - San Francisco
40.14-64.55
Sep 30, 2026