Clinical Research Coordinator HEMONC

About the role

The Clinical Research Coordinator (CRC) will work with a close-knit group of health services researchers and clinicians at the University of California, San Francisco and San Francisco VA Health Care System, who are focused on improving the health of older persons. We are looking for a highly motivated candidate with a strong work ethic who has a background in clinical research or a related field, to assist the Principal Investigator (PI) on a study related to health services.

Responsibilities

• Recruit research subjects (identification, determine eligibility and obtain consent of potential research participants)
• Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure
• Oversee subject reimbursement; work to resolve discrepancies and issues
• Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups
• 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
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed
• Enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner
• Perform queries and analysis in databases
• Prepare, edit and modify documents including research reports, manuscripts, presentations and proposals, including assisting with manuscript and grant writing
• Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures
• Maintain subject tracking systems
• Ensure integrity and security of samples
• Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts
• 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
• Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance
• Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators
• Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed
• Affirm studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations
• Initiate and follow-up on CHR submissions and modifications; track approval status
• Interface with departments to obtain UCSF approval prior to study initiation
• Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments
• 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
• Communicate program, operational, and administrative information to stakeholders through clear written and verbal communication
• Organize and present information, facilitate informed decision-making
• Respond to inquiries, provide clarification, and follow up to ensure issues are addressed and resolved
• Collaborate with internal and external partners to support program and operational needs
• Adjust communication methods and workflows to align with changing organizational priorities and systems

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
• Undergraduate degree or Master’s degree in the health sciences, or related field
• Qualitative research experience including but not limited to conducting interview and focus groups and analyzing qualitative data
• Experience in active listening, empathetic interviewing
• Experience with REDCap, Qualtrics or some other database/survey platforms
• Experience conducting reviews of electronic medical records
• Completes projects in a timely manner, and prioritizes multiple projects to ensure the completion of essential tasks by deadlines
• Understanding of medical terminology
• Ability to create rapport and relationships with diverse patient populations, while also giving insight to what is realistic and appropriate for patient participation
• Knowledge of medical terminology, research policies and guidelines
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
• 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.)
• 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