Clinical Research Coordinator

Job Summary

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 Clinical Research Coordinator will work on the Brain-Computer Restoration of Arm & Voice (BRAVO) Clinical Trial (https://changlab.ucsf.edu/overview) under Dr. Edward Chang in the UCSF Neurosurgery Department. The goal of the BRAVO study is to develop an implantable device that translates brain signals for movement and communication into written text and vocalized speech. The Clinical Research Coordinator will work closely with participants who are quadriplegic and cannot speak. A typical day may include driving to the patient’s home for data collection or working on administrative tasks such as scheduling medical appointments, revising and submitting regulatory documents, recruiting new participants, and ordering medical supplies.

Incumbent’s 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 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 liaison communications with collaborators, assistance with technical set-ups for research data collection, 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, and the like. In all cases, collegial and productive interactions with laboratory personnel, other clinical and research colleagues, administration colleagues, and patients and families will be essential.

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.
• 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.