Part-time Clinical Research Coordinator

Under the supervision of the Clinical Research Supervisor, Clinical Research Coordinators (CRC) support the management of investigator-sponsored research studies as assigned/needed. Responsibilities include communicating with the Clinical Research Supervisor 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 4-5 research studies that are studies in patients with benign urologic diseases. This may include active and 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., enrolling participants, calling participants, administering surveys, etc). 

60

YES

Study Coordination and Data Collection

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Participate in in-person (Mission Bay and Parnassus) and virtual clinics to discuss studies with potential participants, enroll participants, and contact participants for ongoing study follow-up.
• 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 and required data collected at visits.
• 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.

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
• 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

Study Implementation

Protocol Submissions and Adherence

• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
• Work with other centers to facilitate IRB approval
• Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
• Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
• Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be