Assistant CRC

The Assistant Clinical Research Coordinator will assist the PI with clinical research coordination of the following studies:

(1) a pediatric headache study sponsored by PCORI. UCSF is identified as an enrolling site.  Under the PI and Clinical Research Manager; the incumbent may coordinate the data collection and operations of this trial (REACH) Responding with Evidence and Access for Childhood and Headaches under the guidelines of the Code of Federal Regulations, Good Clinical Practice, and UCSF policies. 

(2) a pediatric headache study sponsored by Pfizer. Under the PI and Clinical Research Manager; the incumbent may coordinate the data collection and operations of this study Empowering Children and Adolescents Undergoing Needle-based Procedures for Headache Treatment through Implementation of a “Headache Procedure Comfort Menu”: a Novel Clinical Tool under the guidelines of the Code of Federal Regulations, Good Clinical Practice, and UCSF policies. 

The 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 of varied size and complexity; help in research administration; assist with patient recruitment; help manage patient study source documents; perform data entry to study Case Report Form databases; collect, process and ship study specimens in accordance with study protocols; assist the PI with intermediary services and departments while overseeing data and specimen coordination; report study progress to the PI in regular team meetings; update spreadsheets tracking recruitment efforts; help coordinate subcontracts through collaborative effort with PI; assist with management of all Regulatory aspects of Investigator’s protocols in IRIS, the Committee on Human Research online system, including renewals and modifications of study protocols and the implementation of new studies; ensure study data integrity; assist with implementation of quality control procedures; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned as appropriate. 

% 

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

60%

YES

Patient Management:

• Working in collaboration with others, schedules and tracks patient visits, tests, procedures and follow up according to protocol; provides calendars and schedules to patients; obtains insurance authorization for tests/procedures; in collaboration with team members, codes and documents toxicities and adverse events; reports adverse events to appropriate University and outside agencies; obtains, processes and ships specimens.
• Upon case confirmation and patient follow-up, REDCap access will be provided to check if the patient enrollment is eligible for payment
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Assist with Processing of purchase orders (through Bear Buy) of supplies, computers, office supplies, service agreements, and repair services.
• Help with tracking , receiving, distribution and storage of research supplies using site tracker
• Help with monitoring of expenditures

20%

YES

Patient Registration:

• Works with Investigators to verify history and medical information to assure inclusion/exclusion criteria are met; schedules screening tests and procedures; registers and randomizes patients on trials and/or studies. 

• Assist with obtaining informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure. 
• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
•  
• Abstracts clinical data from medical records; enters data onto case report forms, study flow sheets, and other forms; submits required data and data forms in accordance with accuracy and timeliness requirements of the protocols; addresses and resolves data queries; identifies, investigates and resolves data quality issues
• Maintain source data collection forms for effective data collection, entry, and analysis.  

10%

YES

Data Management:

10%

1.  
2.  
3. Miscellaneous

• Helps prepare for audits/monitoring visits by sponsors and/or regulatory agenci