Clinical Research Coordinator, Surgery

About the Role

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate research protocols. This role may involve coordinating data collection and operations for several concurrent clinical research studies, adhering to research protocols, and UCSF and regulating agency policies.

Key Responsibilities

• Support the management and coordination of single or multiple clinical research studies.
• Act as an intermediary between services and departments, 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.
• Assist Clinical Research Supervisor and/or PI with oversight of other research staff.
• Manage Investigator’s protocols in the Committee on Human Research (CHR) online system, including 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.
• Perform other duties as assigned.

Requirements & Tech Stack

• High School Diploma; or equivalent experience/training.
• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication.
• Ability to multi-task in a fast-paced environment.
• Ability to work with a diverse subject population.
• Skills to coordinate with subjects, team members, other departments, and outside institutions.
• Ability to work well independently.
• Ability to complete projects in a timely manner.
• Ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Preferred Qualifications

• Fluency in the usage of the Committee of Human Research (CHR) online iMEDris 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.
• BS Degree.
• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality and HIPAA regulations.
• Understanding of policies and procedures on patient safety and confidentiality.
• 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 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
• CHR regulations for recruitment and consent of research subjects.
• Experience with Effective Cash Handling Procedures.
• Experience with Environmental Health and Safety Training.
• Experience with Fire Safety Training.