Clinical Research Coordinator
Job Overview:
The Clinical Research Coordinator (CRC) 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.
The CRC’s duties may include, but will not be limited to supporting the management and coordinating 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, and 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.
The CRC will, independently or as directed by the PI, execute, manage and coordinate clinical and/or research protocols, and may coordinate the data collection and operations of several concurrent clinical research studies. Primary responsibilities will include data-collection from patients, generation and dissemination of clinical data and visualizations, conversion of data to usable data formats, and management of data files. Secondary responsibilities include liaison communications with collaborators, assistance with technical set-ups for research data collection, and assistance with experiment planning and study logistics. Other responsibilities may include administrative support for clinical research, including activities relating to regulatory approvals, consent documentation, and the like. In all cases, collegial and productive interactions with laboratory personnel, other clinical and research colleagues, administration colleagues, and patients and families will be essential.
Department Description
The Department of Neurosurgery at UCSF is one of the most pre-emanate neurosurgical departments in the country for clinical care, training and research. The department is number one academic research publication productivity and recently named as one of the top Neurosurgery Training Programs in the country. The Department is also ranked 4th in the nation for Neurosurgery & Neurology and is the number one Neurosurgery Department on the west coast (US News & World Report). Central administration at the Parnassus Heights location is responsible for directing all administrative functions of the department. The department’s Spine Group Team is currently located at UCSF Parnassus Campus.
Required Qualifications
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Fluency in the usage of Committee of Human Research (CHR) online iMedRIS system for submission, renewal, and modification of protocols through this system
• Proficient experience working with MS Office and web-based interfaces
• Experience to rapidly learn and independently utilize new database management systems, e.g., MySQL, SQLite
• Experience working in the context of a hospital or research setting
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Experience in pro-actively applying problem solving skills to maintain database integrity, identifying and correcting errors as needed
• Experience in rapidly learning and understanding clinical challenges faced by the study population and use this knowledge to establish rapport and interact sensitively and effectively with subjects
• 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 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
Preferred Qualifications
• Graduation from college with BA or BS degree in physical or biological sciences or related field and two years of relevant clinical/basic research experience, or an equivalent combination of education and experience
• Experience with electronic medical records
• Knowledge of location specific and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the location's mission statement and purpose for research, and a 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, research policies and guidelines, guidelines for packing/shipping infectious substances, 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, Effective Cash Handling Procedures, Environmental Health and Safety Training, Fire Safety Training
• Experience with multi OS environment to include Windows, Mac OS, Linux/UNIX
• Experience using Committee on Human Research (CHR) online iRIS system for submission, renewal, and modification of protocols through this system
• Experience working with medical imaging
• Quality control procedures: 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
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