Clinical Research Coordinator

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 Clinical Research Coordinator will, independently or as directed by the Principal Investigator (PI, Dr. Chang), execute, manage and coordinate clinical and/or research protocols, and may coordinate the data collection and operations of several concurrent clinical research studies.

Primary responsibilities will include acquisition, preparation, testing, and maintenance of electronic recording hardware, technical set-ups for research data collection in the operative setting, data-collection from patients, generation and dissemination of clinical data and visualizations, conversion of data to usable data formats, and management of data files.

Secondary responsibilities include development and improvement of hardware and software platforms used for data collection, analysis of multi-modal neural and behavioral datasets, and assistance with experiment planning and study logistics.

Other responsibilities may include administrative support for clinical research, including activities relating to regulatory approvals, consent documentation. In all cases, collegial and productive interactions with laboratory personnel, other clinical and research colleagues, administration colleagues, and patients and families will be essential.

• High school 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 and clinically sensitive 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.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Proficient experience working with MS Office and web-based interfaces.
• Experience in pro-actively applying problem solving skills to maintain database integrity, identifying and correcting errors as needed.
• Experience in rapidly learning and understanding clinical challenges faced by the study population with the ability to use this knowledge to establish rapport and interact sensitively and effectively with subjects.
• Experience working in the context of a hospital or research setting.

Preferred Qualifications:

• Graduation with BA or BS in biological or computer sciences or related field

• Relevant clinical/basic research experience.

• Experience with object-oriented programming.

• Fluency in the usage of Committee of Human Research (CHR) IRB-iRIS (formerly iMedRIS) for submission, renewal, and modification of protocols through this system.

• 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. 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 Teleform programming platforms.

• Quality control procedures: Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management. Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry. Implement and maintain periodic quality control procedures

• Experience with multi-OS environment including Windows, Mac OS, Linux/UNIX

• At least 6 months of independent programming/data analysis experience

• Proficiency with programming and data analysis in MATLAB or Python or C++

• Experience with computer-aided design (CAD) software such as SolidWorks or Autodesk Fusion

• Experience with analysis of MR-imaging datasets (diffusion tensor imaging (DTI), functional magnetic resonance imaging (fMRI), 3D "native space" reconstruction and parcellation using FreeSurfer)

• Experience with in-vivo electrophysiological data collection, particularly using Neuropixels probes

• Familiarity with basic principles of electrical engineering

• Familiarity with basic principles of linguistics

• Familiarity with basic human neuroanatomy

• Familiarity with basic principles of neuroscience and neurobiology

• Familiarity with basic principles of neurological disorders related to speech and language

• 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

25%

YES

Study Implementation

• Coordinate acquisition process for high-value experimental equipment and manage associated tracking and customs clearance protocols as needed

• acquisition, preparation, testing, and maintenance of electronic recording hardware, technical set-ups for research data collection in the operative setting

• Assemble and test intraoperative recording devices and associated mechanical and electronic parts, and manage transportation to and from sterilization facilities

• development and improvement of hardware and software platforms used for data collection, analysis of multi-modal neural and behavioral datasets

• Assist with miscellaneous requests for logistical and organizational assistance

• Service as logistical manager for Chang Lab and provide organizational support to Chang Lab Manager

• As needed, manage lab access for personnel and visitors

• Ensure that the laboratory space is functionally organized

• Maintain laboratory inventory in collaboration with Chang Lab Manager and laboratory personnel

• Assistance with experiment planning and study logistics.

• Collect neural and/or behavioral data in neurosurgical procedures involving awake craniotomy for resection of pathological cortical tissue. The incumbent will be obtaining data from the PI and lab staff.

• Assist with multi-modal data collection, technical device set-up, and research and staff responsibilities to enable smooth and successful collection of data

• Track and ensure adequate functioning and availability of study devices

• Maintain calendar of upcoming cases, in collaboration with principal investigator (PI, Dr. Chang) and other attending neurosurgeons at UCSF and keep relevant team members updated regarding upcoming subjects of interest

• Coordinate collection of relevant pre- and post- operative behavioral tasks with research subjects

25%

YES

Study Coordination and Data Collection

45%

YES

Data management and reporting of results

• Maintain list of patient names/MRNs mapped to anonymized data signifiers
• Generate and maintain spreadsheets and other documentation of patient data and study participation details
• Share clinical electrode montages and other clinical data with research team
• Generate and disseminate specialized visualizations of key clinical data
• Provide daily updates on clinical data collection
• Download, convert, store, preprocess, and otherwise manage raw multi-modal data (neural, behavioral, etc.) for use by team members; develop guidance documents for accessing data, as appropriate
• Generate and share data summaries, including graphical presentation and basic statistical analysis
• Prepare summaries and analyses for reports, presentations, and internal laboratory references
• Annotate and/or transcribe multi-modal datasets to enable data mining, as needed
• Manage the storage, conversion and sharing of clinical recordings
• Upload clinical recordings, including audio/video, from clinical servers to Chang lab servers
• Convert all clinical recordings using established software tools; export annotations from each recording; anonymize and upload to appropriate servers
• Transfer converted clinical data to shared directories for use by collaborators; communicate with collaborators to enable easy access and use of shared data
• Maintain and update software infrastructure used for data collection and preprocessing as needed to accommodate new tasks, recording devices, and analysis methods, with support and guidance from team members.
• Maintain regular back-ups of databases and provide backup verification reports

5%

YES

Regulatory Assistance

• Submit Institutional Review Board (IRB) modification forms and personnel changes
• Administrative support for clinical research, including activities relating to regulatory approvals, consent documentation,

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

25%

YES

Study Implementation

• Coordinate acquisition process for high-value experimental equipment and manage associated tracking and customs clearance protocols as needed

• acquisition, preparation, testing, and maintenance of electronic recording hardware, technical set-ups for research data collection in the operative setting

• Assemble and test intraoperative recording devices and associated mechanical and electronic parts, and manage transportation to and from sterilization facilities

• development and improvement of hardware and software platforms used for data collection, analysis of multi-modal neural and behavioral datasets

• Assist with miscellaneous requests for logistical and organizational assistance

• Service as logistical manager for Chang Lab and provide organizational support to Chang Lab Manager

• As needed, manage lab access for personnel and visitors

• Ensure that the laboratory space is functionally organized

• Maintain laboratory inventory in collaboration with Chang Lab Manager and laboratory personnel

• Assistance with experiment planning and study logistics.

• Collect neural and/or behavioral data in neurosurgical procedures involving awake craniotomy for resection of pathological cortical tissue. The incumbent will be obtaining data from the PI and lab staff.

• Assist with multi-modal data collection, technical device set-up, and research and staff responsibilities to enable smooth and successful collection of data

• Track and ensure adequate functioning and availability of study devices

• Maintain calendar of upcoming cases, in collaboration with principal investigator (PI, Dr. Chang) and other attending neurosurgeons at UCSF and keep relevant team members updated regarding upcoming subjects of interest

• Coordinate collection of relevant pre- and post- operative behavioral tasks with research subjects

25%

YES

Study Coordination and Data Collection

45%

YES

Data management and reporting of results

• Maintain list of patient names/MRNs mapped to anonymized data signifiers
• Generate and maintain spreadsheets and other documentation of patient data and study participation details
• Share clinical electrode montages and other clinical data with research team
• Generate and disseminate specialized visualizations of key clinical data
• Provide daily updates on clinical data collection
• Download, convert, store, preprocess, and otherwise manage raw multi-modal data (neural, behavioral, etc.) for use by team members; develop guidance documents for accessing data, as appropriate
• Generate and share data summaries, including graphical presentation and basic statistical analysis
• Prepare summaries and analyses for reports, presentations, and internal laboratory references
• Annotate and/or transcribe multi-modal datasets to enable data mining, as needed
• Manage the storage, conversion and sharing of clinical recordings
• Upload clinical recordings, including audio/video, from clinical servers to Chang lab servers
• Convert all clinical recordings using established software tools; export annotations from each recording; anonymize and upload to appropriate servers
• Transfer converted clinical data to shared directories for use by collaborators; communicate with collaborators to enable easy access and use of shared data
• Maintain and update software infrastructure used for data collection and preprocessing as needed to accommodate new tasks, recording devices, and analysis methods, with support and guidance from team members.
• Maintain regular back-ups of databases and provide backup verification reports

5%

YES

Regulatory Assistance

• Submit Institutional Review Board (IRB) modification forms and personnel changes
• Administrative support for clinical research, including activities relating to regulatory approvals, consent documentation,

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)