Clinical Research Coordinator

% 

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

40%

Patient Recruitment & Visit Coordination

• Work with investigators to screen potential research subjects to determine suitability for research studies
• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Recruit subjects for research studies via phone or in person at various UCSF clinics
• Collaborate with multiple departments to ensure study subjects are scheduled on the correct imaging resource

• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.

• Meet and guide patients through research imaging visits

• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.

• 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.

• Travel between UCSF campuses to meet patients for their imaging visits

30%

Data Collection & Management

• Complete research Case Report Forms and enter data into research databases
• Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• Administer questionnaires, collect medical history and coordinate study procedures
• De-identify and transfer imaging data to study sponsors in accordance with department and UCSF policies
• Resolve queries relating to imaging data and case report forms
• Collect data during subject visits; enter data from visits, procedures, lab tests, 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 CRC Supervisor and/or PI.  
• Maintain data collection forms for effective data collection, entry, and analysis.  
• 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.
• 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.

15%

Study Management

• Keep track of multiple study protocols
• Coordinate clinical studies including IRB submissions, data analysis, data reporting, facilitating sponsor visits, and subject tracking
• Act as liaison to study sponsor and collaborators
• Help prepare for audits/monitoring visits by sponsors and/or regulatory agencies
• Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
• Enter existing and new study protocols into the Committee on Human Research (IRB) online system; seek assistance on maintaining all protocols in the system by communicating with IRB Analysts.
• 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 of protocols and related procedures to ensure institutional review board approval within University compliance.
• Renew, modify, and submit IRB applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF IRB applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

10%

Quality Control & Regulatory Adherence

• 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
• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on IRB submissions and modifications; track approval status.
• Interface with departments to obtain UCSF approval prior to study initiation.
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.

5%

Miscellaneous

• Monitor study supply inventory and reorder as needed; maintain research charts and study binders; and perform other related duties as assigned.
• Attend group and departmental meetings

100%