Clinical Research Coordinator - Division Of HIV

Job Description



Job Summary:



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.



CRC's 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;; assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of 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.



The CRC is being hired to support a large NIH funded research study to use real-time monitoring of alcohol use as the gold standard to determine the best cutoff for an alcohol biomarker called phosphatidylethanol (PEth), that is found in blood tests. The real-time monitoring will be using a wrist-worn biosensor and daily cell-phone based surveys over a 28-day study period. The CRC will conduct screening and enrolling study participants, scheduling study visits, and will conduct all participant facing procedures including gaining informed consent, training and supporting participants on the use of the technology associated with the study, conducting study surveys, performing finger-pricks for blood spot collection, and conducting non-invasive measurements of body composition such as height, weight, waist and hip measurements. The CRC will assist in development and maintaining protocols, conducting real-time checks for data completeness and participant compliance, and will track and distribute study remuneration. The CRC will maintain study specimen tracking and oversee shipping for laboratory analysis. The CRC will report on participant recruitment and retention and may assist with regulatory issues such as IRB compliance and NIH progress reports.



About Division Of Hiv, Infectious Diseases And Global Medicine



The Division of HIV, Infectious Diseases and Global Medicine at the University of California San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division’s work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 36 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.



Qualifications



Required Qualifications:




- High School Diploma; or equivalent experience
- 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 Qualifcations





- Fluency in Spanish
- Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
- Bachelor’s or Master’s degree in biological sciences or public health
- 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 research policies and guidelines,guidelines for packing/shipping non- infectious substances
- 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