Job Description

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) in the Department of Pediatrics. This role will serve within the Division of Rheumatology. This role will be for both the Oakland and San Francisco campuses. 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; 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.

Department and Research Overview:

Pediatric rheumatology helps to diagnose and treat autoimmune conditions that are extremely rare with few FDA approved medications, so working with our team can help to make a huge impact! We are focused on improving the lives of children with autoimmune conditions through both research and educational programming. Our group conducts a wide range of clinical, translational, and outcomes research. Some highlights include:

• Collaborative Network (CARRA): We are an active site in the Childhood Arthritis and Rheumatology Research Alliance (CARRA), a North American research network that conducts multicenter studies and maintains a large patient registry and biorepository to advance treatment and outcomes in rare pediatric rheumatic diseases. This includes patients with juvenile arthritis, pediatric lupus and lupus related conditions, juvenile dermatomyositis (JDM) and others.
• Juvenile Dermatomyositis (JDM): We have a local JDM registry and biorepository called JUMP to facilitate translational research to identify precision medicine approaches that improve care and outcomes for this rare autoimmune disease. We are also part of a clinical trial that is studying the effectiveness of CAR-T therapy for this condition.
• Childhood Lupus and Related Conditions: We have several interventional trials for lupus, that also includes novel CAR-T therapy for the treatment of lupus and scleroderma.
• Health Outcomes and Equity: Research on social determinants of health that includes an important study that is trying to understand how social factors and resilience impact juvenile arthritis disease activity and outcomes. [KS1]

Our Pediatric rheumatology team is made up of 16 clinicians who work at Benioff Children's Hospital at both the San Francisco and Oakland sites, as well as additional satellite clinics. The Pediatric rheumatology service has a range of clinical studies and trials going on, including investigator-initiated trials to industry sponsored trials, local and national clinical research registries and biorepositories, observational trials, retrospective trials. We have 10 active studies, with 2 research coordinators who work across our 2 Benioff Children's Hospital sites (Oakland and San Francisco). We are working to add a full-time coordinator to support our important, growing research efforts. Because this is an exciting and rapidly growing role that spans a broad range of responsibilities and evolving priorities, we are looking for someone who is highly detail-oriented, and comfortable adapting in a fast-paced, dynamic environment.

Responsibilities

approximate%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

30

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 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.

20

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.

5

YES

Staff training

• 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.
• 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.

5

YES
Quality control procedures
10

YES
Study Implementation

5

YES

Administrative and Educational Support for Specialized Patient Programs

Assist operations and educational/supportive programming for specialized patient programs such the JDM Center of Excellence and the Wellness Center for Youth with Chronic Conditions

5

YES
Specimen Management/ Maintenance

10

YES

Protocol Submissions and Adherence

• 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.

10

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.

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%.)

Qualifications

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, other departments and outside institutions and companies; and the 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, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Fluent in Spanish.
• Essential to be able to work in both the Oakland and MIssion Bay Locations.

Preferred Qualifications

• College Graduate with a BS or BA in field of biology or other related science, with and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• At least two years' experience in a clinical research setting
• 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

• 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.
• Experience with electronic medical records, preferably EPIC.
• Experience conducting qualitative interviews/focus groups.
• 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.

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