Clinical Research Coordinator Rheumatology

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.

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.