Clinical Research Coordinator Assistant
Job Description
The Assistant 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 Clinical Research Team and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.
This Assistant CRC position will work closely with the UCSF Pediatric Critical Care Clinical Research Group (https://pc3rg.ucsf.edu/). The PC3RG is a team of physicians in the Department of Pediatrics, Division of Critical Care Medicine that practices medicine in the Pediatric Intensive Care Units of UCSF Benioff Children's Hospital at both the San Francisco and Oakland campuses. We staff over 60 pediatric critical care beds and treat a variety of diseases ranging from pneumonia, sepsis, trauma, and multi-organ failure in patients ranging from newborn to over 21 years old with baseline health ranging from healthy to complex medical conditions like cancer and congenital heart disease. Our team maintains a portfolio of 10-15 active studies including interventional clinical trials that test new therapies and observational studies that collect clinical data and research biospecimens to generate new scientific knowledge. At UCSF, we believe that sick children should have access to the most cutting edge medical care and should also have the opportunity to participate in research and contribute to new discoveries. The role of the Assistant CRC is to help execute these studies, ranging from study start-up (eg: IRB submission, training), screening the hospital for eligible patients, consenting and enrolling patients in the ICUs with physician support, collecting clinical data in the electronic medical record (EMR), collecting biospecimens from patients such as blood and respiratory samples with physician and nursing support, and following-up with patients through and after discharge. This is a dynamic and exciting job with in-hospital patient contact and exposure to physicians, nurses, and hospital systems.
% of time | Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
25% | YES | Study Coordination and Data Collection
|
25% | YES | Data management
|
5% | YES |
Staff training
|
20% | YES | Specimen Collection, Processing and Shipping |
25% | YES | Regulatory Approval and Maintenance
|
100% | (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) |
Required Qualifications
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members and outside institutions;
The ability to multi-task in a fast-paced environment while working with a diverse subject population.
Willingness to maintain a flexible work schedule within a clinical research team.
Ability to work well independently and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
College graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
Preferred Qualifications
Spanish language fluency.
Experience with electronic medical records.
Fluency in the process of obtaining Committee of Human Research (CHR) approval including the online iMEDris system for submission, renewal, and modification of protocols.
Practical knowledge of human subjects research including confidentiality and HIPPA regulations; medical terminology, research policies and guidelines.
RN degree and/or practical clinical experience in a Children’s Hospital or ICU environment.
Guidelines for safe packing/shipping human samples.
Experience applying the following regulations and guidelines:
Clinical Research Good Clinical Practice
Health Information and Accountability Act (HIPAA)
The Protection of Human Research Subjects
CHR regulations for recruitment and consent of research subjects
Environmental Health and Safety Training