Clinical Research Coordinator

University of California, San Francisco

About the Role

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate research protocols independently or with general direction. The CRC will assist neurologists and other members of the clinical and research team in the Movement Disorders and Neuromodulation division with the coordination of clinical research studies and clinical care for patients with Parkinson’s disease and other movement disorders.

Key Responsibilities

• Coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies.
• Coordinate clinical research studies and clinical care, including drug treatments and observational studies.
• Interact with patients.
• Coordinate and attend complex clinic and study visits.
• Collect research data and manage databases.
• Collect, process, and ship biological specimens.
• Manage research case report forms and supplies.
• Manage regulatory documents.
• Support management and coordinate tasks for single or multiple clinical research studies.
• Act as an 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 with oversight of other research staff.
• Manage Investigator’s protocols in the Committee on Human Research online system.
• Manage renewals and modifications of protocol applications.
• Implement 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 to coordinate with subjects, team members, other departments, and outside institutions.
• 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.
• Knowledge of clinical research regulations and guidelines, including:
• Good Clinical Practice (GCP)
• Human Subjects Protection regulations
• Health Insurance Portability and Accountability Act (HIPAA)
• Institutional Review Board (IRB) processes and compliance requirements
• Experience coordinating clinical research studies, including participant recruitment, informed consent procedures, study visit coordination, and protocol implementation.
• Experience collecting, documenting, and managing research data, including completion and maintenance of case report forms (CRFs) and maintaining accurate study records.
• Ability to accurately execute Clinical Research protocols in a timely manner.
• Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
• Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
• Experience collecting, processing, and coordinating the shipment of biological specimens in accordance with study protocols and safety regulations.
• Strong organizational, analytical, and problem-solving skills, with demonstrated ability to manage detailed documentation and maintain data integrity.
• Effective interpersonal and communication skills, with the ability to collaborate with investigators, clinicians, research staff, and external partners.
• Proficiency with Microsoft Office software (Word, Excel, etc.).
• Excellent problem-solving skills.
• Interest and ability to work with participants in a Clinical Research setting.
• Ability to work onsite depending on project needs.
• Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.

Qualifications

• HS graduation and experience in clinical research coordination, clinical research operations, or related research environment involving human subjects.