Clinical Research Coordinator Rheumatology

About the role

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.

Responsibilities

• 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. 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.
• 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.
• 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. Ensure integrity and security of samples.
• 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.

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.
• Fluency in Spanish. Essential to be able to work in both the Oakland and Mission Bay Locations.