Clin Rsch Crd

University of California, San Francisco•San Francisco, CA

About The Position

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.

Requirements

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
Ability to complete projects in a timely manner
Ability to 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

Nice To Haves

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
Familiarity with protection of human subjects
Familiarity with creating tables and figures for publication
Familiarity with 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
Knowledge of research policies and guidelines
Knowledge of 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

Responsibilities

Enrolling patients in clinical studies
Data entry and management
Biospecimen collection and processing
Attending and documenting proceedings at relevant meetings
Preparing grant proposals and reports, peer-reviewed manuscripts, and abstracts
Completion of regulatory documents
Institutional Review Board applications, revisions and reports
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
Completing renewals and modifications of protocol applications and the implementation of new studies with PI oversight
Participating in the review and writing of protocols to ensure institutional review board approval within University compliance
Helping to assure compliance with all relevant regulatory agencies
Overseeing study data integrity
Interfacing with departments to obtain UCSF approval prior to study initiation
Completing and maintaining all regulatory documents
Reporting study progress to investigators
Participating in manuscript, grant, and abstract preparation and submission
Participating in any internal and external audits or reviews of study protocols