Clinical Research Coordinator

About the Role

This is a 50% position (20 hours per week) involving on-site study visits at UCSF Benioff Children’s Hospitals in San Francisco (Mission Bay) and Oakland. Flexibility is required as the work location and daily hours will be determined by study needs.

• The position is primarily Monday through Friday.
• Daily hours vary weekly based on study demands.
• Most study visits commence in the morning, with an approximate arrival time of 7:30 am at UCSF locations.
• Occasional evening hours (6 or 7 pm) and very rare weekend hours may be required for phone calls regarding the study, usually conducted remotely.
• There is potential to increase weekly hours in the future.
• Some remote work may be possible based on study needs and current department policies.

The Clinical Research Coordinator (CRC) independently manages and coordinates research protocols, primarily for children with hormone conditions, under general direction. The role involves executing, managing, and coordinating research protocols as directed by the Clinical Research Supervisor and/or Principal Investigator (PI). This includes coordinating data collection and operations for multiple concurrent clinical research studies in accordance with research protocols, UCSF policies, and regulating agency policies.

Key Responsibilities

• Oversee multiple clinical studies.
• Ensure regulatory compliance.
• Manage data and documentation.
• Support IRB submissions.
• Maintain data quality.
• Coordinate staff activities.
• Participate in audits.
• Adhere to UCSF policies and research guidelines.
• Act as an intermediary between services and departments.
• Oversee 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.
• 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, including renewals and modifications of protocol applications.
• Implement new studies.
• Participate in the review and writing of protocols to ensure IRB approval within University compliance.
• Ensure 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 internal and external audits or reviews of study protocols.
• Recruit participants for multiple studies in pediatric endocrinology via phone, email, Zoom/video, or in person.
• Work closely with researchers, hospital clinic staff, children, and their families.
• Perform other duties as assigned.

Requirements & Tech Stack

• High School Diploma or equivalent experience.
• Proficiency with Microsoft Word, PowerPoint, Excel, Outlook, and Windows.
• Experience working with children, adolescents, and families.
• Fluency in the usage of Institutional Review Board (IRB) online iRIS system.
• Experience with accessing electronic medical records and entering data into RECAP and other platforms.
• Knowledge of UCSF and departmental policies regarding reimbursement, research guidelines, confidentiality, and HIPAA.
• Understanding of patient safety and confidentiality policies (electronic and hard copy medical records, patient charts, communication).
• Knowledge of medical terminology.
• Knowledge of research policies and guidelines.
• Knowledge of guidelines for packing/shipping infectious substances.
• Knowledge of database building/analysis and data management within platforms such as Access, Stata, SASS/ SPSS, and Teleform.
• 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

Qualifications

• Excellent verbal and written communication, organizational, and interpersonal skills to work effectively in a diverse team.
• Attention to detail.
• Ability to multitask 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 task completion by deadlines.
• Excellent analytical and problem-solving skills.
• Ability to establish cooperative working relationships with patients, co-workers, and physicians.
• Career interest in working with children and/or adolescents and their families.
• Understanding of the patient population to create rapport and provide appropriate insight into patient participation.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.