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 Manager, 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.

The duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; 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; coordinate staff work schedules, assist with training of Assistant CRCs and other CRC team members, and assist Research Personnel Manager and/or PI with oversight of other research staff; 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 relevant regulatory documents in partnership with the Regulatory department; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Department Overview:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI).

The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• 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.

• Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
  

• Prior experience with various computer programs (Microsoft Office; internet-based databases) and using specialized software such as OnCore.
• Ability to sit and work at a computer for several hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day.
• Experience in clinical research or demonstrated knowledge of research or training experience that translates into a clinical research setting. Familiarity with specimen processing
• Working knowledge of federal, state, and local research regulations and guidelines, and research practice methods in a laboratory or clinical setting
• Ability to apply relevant information to the assessment, interpretation, and processing of medical data.
• Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environment

• Ability to work with a sensitive population of patients (oncology patients)
  

  Preferred Qualifications:

• Prior analytical and writing skills in a science/research environment
• 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, SASS/ SPSS, and Teleform programming platforms.
• Knowledge of clinical research in breast oncology
• Knowledge and experience in managing oncology clinical trials.
• Membership in a clinical research professional society.
• 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