Assistant Clinical Research Coordinator

The UCSF Bronchiectasis and Pulmonary Nontuberculous Mycobacterium (NTM) program comprises clinicians from the Pulmonary and Infectious Disease divisions who collaborate to care for patients with complex pulmonary disease and pulmonary infections. Research, including clinical trials of new therapeutics and prospective observational studies, is a critical part of the program’s mission. The program is seeking an Assistant Clinical Research Coordinator (aCRC) to assist with the daily operations of our research enterprise. 

The aCRC will be trained by investigators with the Divisions of Pulmonary Medicine and Infectious Diseases and by an existing network of CRCs and aCRCs within the division. The aCRC will perform entry-level duties related to the execution, management, and coordination of research protocols, as directed by the Principal Investigator (PI) and/or Co-Investigator (co-I). The incumbent will coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies. Activities will be supervised by a senior CRC, PI, and co-PI.

The 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; acting as intermediary between services and departments while overseeing data and specimen management; managing and reporting on study results; creating, cleaning, updating, and managing databases and comprehensive reports; managing the Investigators’ protocols in the Committee on Human Research online system and central IRB systems, as well as renewals and modifications of protocol applications and the implementation of new studies, under the supervision of the PI or senior CRC; participating in the review and writing of protocols to ensure institutional review board approval within University compliance; helping assure compliance with all relevant regulatory agencies; overseeing study data integrity; interfacing with departments to obtain UCSF approval prior to study initiation; maintaining all regulatory documents; reporting study progress to investigators; participating in any internal and external audits or reviews of study protocols; resolves operational aspects of clinical studies or trials in conjunction with PI and senior CRC in accordance with standard operating procedures and good clinical practice and regulations; and performing other duties as assigned. 

% 

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

30

YES

Study Coordination and Data Collection

Receive training on how to, and work under CRC and investigators to:

• Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
• Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform 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, specimens properly stored, and 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.
• 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.

30

YES

Data management and reporting of results

Receive training on how to, and under supervision with a CRC:

• Abstract clinical data from medical records (i.e. procedures, lab tests, and other subject-related participation) enter data onto case report forms for The Primary Ciliary Dyskinesia Foundation and the Bronchiectasis Patient Registry in a timely manner.

• Develop and maintain Excel spreadsheets 

• Prepare reports from Apex reports on clinic attendance and health screening 

• Address and resolve data queries

• Identify, i