Clinical Research Coordinator
University of California San Francisco
The Clinical Research Coordinator will work with faculty, fellows and residents to organize and participate in all operational aspects of ongoing clinical and health services research in Emergency Medicine. Working under the supervision of the Principal Investigators, the position's duties include enrolling patients in clinical studies, data entry and management, biospecimen collection and processing, attending and documenting the proceedings at relevant meetings, and preparing grant proposals and reports, peer-reviewed manuscripts, and abstracts. Additional duties will include completion of regulatory documents, Institutional Review Board applications, revisions and reports, and other duties as assigned.
Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical and health services research studies; acting as the intermediary between services and departments while overseeing data and specimen management; managing and reporting on study results; creating, cleaning, updating, and managing databases and comprehensive datasets and reports; managing Investigator's protocols in the Committee on Human Research online system, and completing renewals and modifications of protocol applications and the implementation of new studies with PI oversight. In addition, the Coordinator will 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; interface with departments to obtain UCSF approval prior to study initiation; complete and maintain all regulatory documents; report study progress to investigators; participate in manuscript, grant, and abstract preparation and submission; and participate in any internal and external audits or reviews of study protocols.
Qualifications
Required:
- 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.
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
Preferred:
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system or other IRB systems for submission, renewal, and modification of protocols
- Familiarity with data management/analysis programs, including some of the following: Microsoft Excel, Access, Stata, SASS/ SPSS, REDCap and Teleform programming platforms.
- Fluency in the usage of Microsoft word
- Familiarity with grant preparation, protection of human subjects, creating tables and figures for publication, manuscript preparation and submission
- Obtaining research publications from library/online sources for literature searches
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
- Experience with electronic medical records.
- Spanish language fluency
- Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF 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,
- 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
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