Job Description

The overall goal of the position is to support the developing research enterprises of the Child Health Advanced Molecular Phenotyping (CHAMP) Program, which is designed to help investigators better understand childhood disease by making high-quality human biological samples and molecular data more accessible across UCSF.

Many serious pediatric illnesses remain difficult to explain using traditional clinical information alone. CHAMP addresses this gap by supporting the careful collection, processing, preservation, and study of biological samples from children across a wide range of diseases and clinical settings. The goal is to make it easier for researchers to connect what is happening in a child's body at the molecular and cellular level with the clinical course of illness.

CHAMP is built around two complementary goals. The first is to create a coordinated infrastructure for collecting biofluids and tissues from willing participants, especially children with severe, rare, or poorly understood diseases. Whenever possible, samples are obtained from the sites most relevant to disease and are processed using protocols designed to preserve their value for both current and future technologies.

The second goal is to pair these samples with advanced molecular profiling platforms that can generate detailed information about immune responses, gene expression, cellular states, antibodies, pathogens, and other features of disease biology. These data can then be used by investigators across UCSF to generate new hypotheses, identify disease mechanisms, and ultimately improve diagnosis and treatment for children.

CHAMP operates under IRB-approved protocols that allow collection of human biofluids and tissues, including biopsy and post-mortem specimens, across organ systems and age groups. The program has developed workflows for rapid processing, cryopreservation, and live cell preservation so that valuable samples can be studied with the best available technologies.

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 Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of two concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

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; 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.

%

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

25%

YES

Study Coordination and Data Collection

• 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 historyand 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.

25

YES

Data management and reporting of results

• 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.

25%

YES

Specimen Management/ Maintenance

• 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.

25%

YES

Regulatory responsibilities

• 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.

10 0%

(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:

• High School Diploma; or equivalent experience
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members and outside institutions
• Proficiency with Microsoft Word, PowerPoint, and Windows
• Excellent analytical and problem-solving skills
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects
• Ability to establish cooperative working relationships with patients, co-workers, & physicians

Preferred Qualifications:

• Spanish language fluency

• Demonstrated proficiency with medical terminology

• Experience working with patients or study subjects

• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases