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 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.

The incumbent’s duties may include, but will not be limited to the coordination of activities in research studies focused on sleep disruption in healthy aging and neurodegenerative diseases. They will act as intermediary between services and departments while overseeing data and specimen management; will utilize electrophysiological sleep equipment and electroencephalography collection; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules and assist with training of Assistant CRCs; manage Investigator’s protocols in the Committee on Human Research and Western Institution Board online systems, 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 and attend team meetings; prepare at-home movement and sleep measuring devices; administer and analyze sleep and circadian recording; administer cognitive tests; and perform other duties as assigned. A proportion of this position will take place off-site, typically in a hotel setting, and will require having reliable transportation to various locations throughout the Bay Area. It will require flexible evening hours and may also require flexible daytime hours. 
 

% 

of time (Nothing less than 5%)

Essential Function (Yes/No)

  

Key Responsibilities

(To be completed by Supervisor)

30%

YES

Study Coordination and Patient Management 

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits; meet with them to administer questionnaires, train them on sleep equipment, collect medical history, and perform other 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; 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.

30%

YES

Data and Equipment Management 

• Collect data during subject visits; enter data from visits, procedures, and other subject-related participation into databases in a timely manner.
• 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 PI.  
• Maintain data collection forms for effective data collection, entry, and analysis.  
• Perform queries and analysis in databases.
• Maintain complete and accurate data in the study database; analyze the data as they become available.
• Ensure electrode and sensor recording integrity by troubleshooting common recognizable defects/malfunctions.
• Manage the maintenance of the polysomnography equipment and at-home sleep/circadian and cognitive testing supplies.
• Check proper