Clinical Research Coordinator

The Clinical Research Coordinator's duties may include, but will not be limited to, coordinating the tasks of multiple clinical research studies within the Department of Emergency Medicine; 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; train research volunteers; coordinate all 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; and perform 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.

Department Overview:

UCSF Fresno is a regional campus of UCSF located in California's Central San Joaquin Valley and administered by the Office of the Vice Dean in Fresno.

The UCSF Fresno Department of Emergency Medicine is a medium-to large-sized academic department,
with 46 residents, three fellows, 75 faculty, 16 midlevel providers, and approximately 60 medical student rotators. Founded in 1974 at Valley Medical Center in Fresno County, the Emergency Medicine residency is one of the first EM programs in the country.

The UCSF Fresno Emergency Medicine Department provides service and training at the affiliated locations: Community Regional Medical Center, Clovis Community Medical Center, and Kaiser Permanente Fresno. The Department's mission is: Advancing Emergency Medicine through exceptional education, patient care, research, and collaboration.

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 the 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 multi-disciplinary team of lecturers who can 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-a-longs 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 to develop and maintain 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.

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 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

• Excellent writing skills.

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 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

• Excellent writing skills.