Clinical Research Coordinator

Job Description A Clinical Research Coordinator coordinates the tasks of multiple clinical research studies within the Department of Emergency Medicine, acts as an intermediary between services and departments, oversees data and specimen management, manages and reports on study results, creates, cleans, updates and manages databases and comprehensive data sets and reports, trains research volunteers, coordinates protocol applications and implementation of new studies, participates in the review and writing of protocols to ensure institutional review board approval within University compliance, helps assure compliance with all relevant regulatory agencies, oversees study data integrity, implements and maintains periodic quality control procedures, interfaces with departments to obtain UCSF approval prior to study initiation, maintains all regulatory documents and reports study progress to investigators, participates in any internal and external audits or reviews of study protocols, and performs other duties as assigned. This position reports to the department's Administrative Manager for operational, administrative, and financial matters, and to the Research Director for research direction and regulatory compliance. Responsibilities 20% Study Coordination Prepare all relevant Institutional Review Board (IRB) paperwork (e.g., initial review documents, study renewals/closure reports, adverse events, study modifications, etc.). Review, edit, and format all research protocols and consent documents before submitting all materials through CyberIRB. Obtain informed consent; review information with subjects; conduct follow-up calls; assess and advocate for patient safety throughout each protocol procedure. Oversee subject reimbursement; work to resolve discrepancies and issues. Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies. Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration. Act as liaison between departments, stakeholders, and UCSF. Respond to queries from the IRB in a timely manner. 20% Data Management Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Maintain data collection forms for effective data collection, entry, and analysis. Maintain electronic study records and regulatory study binders. Maintain research log in Microsoft Excel of all ongoing projects in Emergency Medicine. Work with study PIs to ensure compliance with clinical protocols and federal guidelines. Maintain records of Human Subjects Protection Training for all personnel involved in departmental research studies. 25% Staff, research associates, and volunteer training and coordination Help train staff, research associates/volunteers, and others on new research protocols, research fundamentals, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures. Assist research director with development and updates to a curriculum for volunteer research associates that covers clinical research fundamentals. Support research director with the selection, training, and utilization of volunteer research associates. Help research director guide research associates/volunteers in developing study proposals. Assist with scheduling a multidisciplinary team of lecturers to speak to volunteers about their specific department’s role. Maintain training tools and quizzes to help research director assess research associates’/volunteers’ knowledge. Coordinate mock consent trainings to ensure research assistants can appropriately and effectively interact with patients. Submit grades as provided by the research director, to Fresno State for students receiving credit for volunteer work. Coordinate scheduling shifts, shadowing shifts, and EMS ride‑alongs for research associates/volunteers. 15% Study Implementation Create advertisements, reminders, and procedural documents for each study and ensure their proper application. Submit data request forms, operational feasibility applications, and study protocols to appropriate departments. Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue developing and maintaining systems for assuring protocol adherence and data quality. Ensure study folders contain plenty of data collection sheets for active subject enrollment. Collect and store study data inside UCSF Fresno’s Clinical Research Center. Ensure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. 5% Grants and Contracts Track expenditures for grants. Submit annual reports to funding agencies. Assist with grant proposal writing, editing, and submissions. 15% General Assigned Duties Facilitate investigator meetings and conference calls as needed. Maintain a tracking log of Emergency Medicine residents’ research requirements. Prepare and submit abstracts to national meetings. Serve as a contact for research volunteers, rotating medical students, and pre‑med students. Perform literature reviews as necessary. Qualifications Required Qualifications HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. 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 Bachelor's degree in a related field. Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system. 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. Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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. Excellent writing skills. Equal Employment Opportunity The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law. Salary & Benefits The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. To learn more about the benefits of working at UCSF, including total compensation, please visit #J-18808-Ljbffr