Clinical Research Coordinator

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). May coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Key Responsibilities

• Support the management and coordinate 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.
• 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, 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.
• Perform other duties as assigned.

Requirements & Tech Stack

• Attention to detail
• Strong interpersonal skills
• Excellent, effective verbal and written communication skills
• Ability to multi-task in a fast-paced environment
• Ability to work with a diverse subject population
• 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.
• Knowledge of research on Human Immunodeficiency Virus (HIV)
• Fluency in the usage of Committee of Human Research (CHR) online system
• Experience with electronic medical records
• Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, and HIPAA regulations.
• 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.
• Knowledge of research policies and guidelines.
• Knowledge of guidelines for packing/shipping infectious substances.
• Knowledge of database building/analysis.
• Knowledge of 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
• Effective Cash Handling Procedures
• Environmental Health and Safety Training
• Fire Safety Training

Qualifications

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.

Preferred Qualifications

• Ability to read and write in Spanish.
• Experience with populations who use drugs.