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 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 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.
Involves analytical studies on a variety of policies, projects, programs and issues in support of a function, research initiative, program and / or organizational unit, or in research of new or changing systems and programs. Assists in policy and program planning, development, administration, management and implementation; interprets, monitors and analyzes information regarding policies and procedures and provides consultative services to department administrators and other stakeholders.
Under the direction and supervision of the Principal Investigator (PI) – Dr. Orlando Harris, the Clinical Research Coordinator  will mainly conduct data collection, engage in participant recruitment activities, serves as a center coordinator for the California Center for HIV Syndemic Policy Research (CalCenSyn), strong community engagement with local and state-level community-based organizations, and coordinate lab meetings with graduate research assistants, and coordinate meetings across several state and National Institute of Health sponsored projects.
This position requires a strict adherence to protocols and guidelines, with an emphasis on organizational skills and meticulous attention to detail. In addition, the successful candidate must possess a warm and nonjudgmental manner, and consistently demonstrate interpersonal tact, discretion, and sensitivity when interacting with study participants. These different job aspects are unique processes requiring specific experience and skill sets, and the Clinical Research Coordinator must blend and balance all areas to ensure the successful completion of research data collection and outcomes.
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Department Overview:
The UCSF School of Nursing was founded in 1939 as the first autonomous School of Nursing in any state university, the USCF School of Nursing was the first university west of the Mississippi to offer a doctoral degree in nursing. The UCSF School of Nursing was ranked number 3 in the US News America’s Best Graduate Schools 2016. Since 2003, the school has been ranked first or second in NIH funding, with almost $14 million in 2021. It is designated as a World Health Organization Collaborating Center in Nursing. The UCSF School of Nursing is home to 533 students distributed across five units: the Departments of Physiological Nursing, Family Health Care Nursing, Community Health Systems, Social and Behavioral Sciences, and the Institute for Health and Aging. The PhD program includes 120 doctorally prepared faculty members, of whom 48 actively support the doctoral program. A Center for Symptom Management promotes cross-departmental and multidisciplinary research focusing on interventions to prevent and alleviate symptoms. A number of other centers of research excellence investigate significant problems in acute and chronic care, and policy.
The Department of Community Health Systems (CHS) is based in the school of nursing. CHS promotes and sustains health in the community and workplace, with particular emphasis on culturally diverse and high-risk populations. The department is committed to improving health and health care for those served by community-based health care systems through educating culturally competent nurses, conducting research, and providing services in the community which address the health issues of those underserved by the traditional institution-based health care system. CHS carriers out research on a broad range of HIV-related topics both nationally and internationally, strongly encourages multidisciplinary collaborations across campus, and hosts frequent research seminars and quarterly half-day workshops on emerging, novel research methodology. Faculty research in CHS contributes to our understanding of the effects of disease or conditions on vulnerable populations including: homeless and disadvantaged people and communities, persons with psychiatric disorders and issues of trauma and abuse, high-risk infants and children, individuals with chronic diseases like asthma, cardiovascular disease, diabetes and HIV, and ethnic and immigrant minorities.Â
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Responsibilities
%Â of time (Nothing less than 5%) | Essential Function (Yes/No) | Â Â Key Responsibilities (To be completed by Supervisor) |
30 | YES | Study Coordination and Data Collection
The primary responsibilities will be:
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20 | YES | Data management and reporting of results
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5 | Â | Staff training
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5 | YES | Quality control procedures |
20 | YES | Study Implementation |
15 | YES | Protocol Submissions and Adherence
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5 | YES | Regulatory responsibilities
Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. |
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100% | Â | (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) |
Qualifications
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.
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Preferred Qualifications
- 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.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals Â
- 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: Â 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 TrainingÂ
Fire Safety Training
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