Clinical Research Coordinator

This position is fully onsite in both San Francisco and Oakland. Flexibility is required, the needs of the study will determine the work location on any given day. Work location can generally be planned in advance, but may change on short notice. The position requires fluency in written and spoken Spanish.

The main study for this position is called the NIH DISCOVERY of Risk Factors for Type 2 Diabetes in Youth.

The study coordinator for the DISCOVERY study aims to enroll 10-12 participants per month across the two main hospitals in San Francisco and Oakland. This requires the coordinator to review the upcoming patients in both San Francisco and Oakland and develop a schedule to meet them in person at their clinic visits. 

The study coordinator will work closely with youth at-risk for type 2 diabetes (T2D) and their families, to enroll the children in the study and facilitate the collection of biological samples for analysis.

The knowledge gained from this study of the pathophysiology and epidemiology of youth-onset T2D with deep biochemical, clinical, and psychosocial phenotyping will critically inform the design and testing of future treatment and prevention approaches.

We invite candidates to please address the following questions in your cover letter:

1. What skills and experience do you have that make you a good fit for this position?
2. Describe your experience with research, clinical trials, working with patients, children, families, or diabetes.
3. Describe your organizational skills and provide an example of how you handle competing priorities.
4. What are your plans for the next 2-3+ years (are you planning to go back to school, if so, what program/timeline for matriculation, etc.)?
5. Do you speak any other languages? If so, which one(s)?
6. This position is fully onsite, 5 days per week, Monday through Friday, at either the UCSF Mission Bay Campus or UCSF Oakland Campus. The number of days at each site vary each week depending on the needs of the studies. The hours are generally 40 hours per week, with rare evening and weekend hours. Are you able to commit to this schedule?
7. If selected for this position, when would you be able to start?

The Clinical Research Coordinator (CRC) under general direction, independently manages and coordinates research protocols mainly for pre diabetes and type 2 diabetes in youth. They 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. Responsibilities include overseeing multiple clinical studies, ensuring regulatory compliance, managing data and documentation, supporting IRB submissions, maintaining data quality, coordinating staff activities, and participating in audits while adhering to UCSF policies and research guidelines.

Duties may include, but are not 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 Institutional Review Board (iRIS) 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.

Other duties will include recruiting participants for multiple studies in pediatric endocrinology, including contacting participants by phone, email, Zoom/video, or in person. The majority of these studies will require working closely with other researchers, hospital clinic staff, children and their families, onsite, at both Benioff Children’s Hospitals in San Francisco (West Bay) and in Oakland (East Bay). 

Required Qualifications 

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Excellent verbal and written communication 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, other departments, and outside institutions; 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.
• Fluency in written and spoken Spanish. 
• Proficiency with Microsoft Word, PowerPoint, Excel, Outlook, 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. 
• Experience and comfortable working with children, adolescents and families.

Preferred Qualifications

• Career interest in working with children and/or adolescents and their families.
• Fluency in the usage of Institutional Review Board (IRB) online iRIS 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 accessing electronic medical records and entering the data into REDCap and other platforms.
• 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
  • IRB regulations for recruitment and consent of research subjects
  • Effective Cash Handling Procedures
  • Environmental Health and Safety Training 
  • Fire Safety Training