Clinical Research Coordinator - Pediatric Critical Care

University of California, San Francisco•San Francisco, CA

1d•Onsite

About The Position

The 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 Supervisor 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. 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, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned. This 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.

Requirements

High School Diploma; or equivalent experience/training
Attention to detail
strong interpersonal skills
excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
ability to multi-task in a fast-paced environment while working with a diverse subject population
Ability to work well independently
complete projects in a timely manner
prioritize multiple projects to ensure the completion of essential tasks by deadlines

Nice To Haves

Bachelor's degree in related area; or equivalent experience/training
Bilingual Spanish/English speaker with experience communicating in Spanish with monolingual families over participation in clinical research.
Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
Experience with electronic medical records
Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines, Health Information and Accountability Act (HIPAA), The Protection of Human Research Subjects, CHR regulations for recruitment and consent of research subjects, Effective Cash Handling Procedures, Environmental Health and Safety Training, Fire Safety Training

Responsibilities

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.
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.
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.
Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
Attend and actively participate in regular team meetings.
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.
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.
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.
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 modified; evaluate protocols on an ongoing basis and implement improvements as needed.
Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
Initiate and follow-up on CHR 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.
Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.