CLIN RSCH CRD

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Incumbent's duties may include, but will not be limited to, supporting the management and coordination of single or multiple clinical research studies, depending on their size and complexity; helping design flow sheets, data forms, and source documents; applying inclusion and exclusion criteria for protocols; recruiting, enrolling, registering, scheduling, and retaining study subjects; assisting research personnel to keep patients on study schedules; collecting, entering, cleaning, and maintaining high-quality data in study databases; assisting with data analysis and preparation of reports and tables; attending team meetings; acting as intermediary between services and departments while overseeing data and specimen management; managing and reporting study results; creating and maintaining databases, datasets, and reports; coordinating staff schedules, assisting with training of Assistant CRCs, and supporting the Clinical Research Supervisor and/or PI with oversight of research staff; managing Investigator protocols and submissions in the Committee on Human Research online system, including renewals, modifications, and new study implementations; participating in the review and writing of protocols to ensure institutional review board approval and regulatory compliance; maintaining regulatory documents and ensuring compliance with all relevant agencies; implementing and maintaining quality control procedures to ensure study data integrity; obtaining required institutional approvals prior to study initiation; reporting study progress to investigators; participating in internal and external audits or reviews of study protocols; and performing other duties as assigned.

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with Microsoft Word, PowerPoint, and Windows/Mac
• Database management skills (Excel/Access/RedCAP)
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.
• 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:

• Experience working with patients or study subjects.
• Interest and/or working knowledge of neuroanatomy & cognitive test administration skills.
• Demonstrated ability to abstract data from medical records and transfer it to data collection forms or directly into databases
• Working knowledge of basic statistics.
• 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 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, database building/analysis, and data management within some of the following: Access, Stata, R, SAS/SPSS.
• 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

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Proficiency with Microsoft Word, PowerPoint, and Windows/Mac
• Database management skills (Excel/Access/RedCAP)
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.
• 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:

• Experience working with patients or study subjects.
• Interest and/or working knowledge of neuroanatomy & cognitive test administration skills.
• Demonstrated ability to abstract data from medical records and transfer it to data collection forms or directly into databases
• Working knowledge of basic statistics.
• 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 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, database building/analysis, and data management within some of the following: Access, Stata, R, SAS/SPSS.
• 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