Clinical Research Coordinator

This is a limited appointment.

We are looking for a Clinical Research Coordinator who is passionate about addressing health disparities, as well having a familiarity with chronic disease management and clinical trials. This position will function as a member of a multidisciplinary research team and as someone who has experience working in care settings serving low-income patients. Experience working with racially, ethnically diverse, and lower health literacy patient populations is desired.

This role requires a high level of comfort and skill with communicating with a diverse range of stakeholders in the public health setting. This role 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 Project Manager, Project Coordinator, and/or Principal Investigators (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 CRC will be asked to help with INS2PiRED (Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations), a randomized controlled trial (RCT) evaluating strategies to improve hypertension control through self-measured blood pressure (SMBP) monitoring in urban safety-net healthcare systems serving low-income and racially/ethnically diverse populations. The study aims to increase adoption and sustained use of SMBP monitoring among English-, Spanish-, and Cantonese-speaking adults with uncontrolled hypertension across six primary care clinic sites.

The project includes a patient-level randomized controlled trial enrolling 330 participants who will be randomized to either a low-intensity intervention consisting of SMBP education and text-message reminders, or a high-intensity intervention that additionally incorporates group classes and caregiver engagement. Concurrently, the study will implement clinic-level strategies to improve integration of SMBP data into clinical care workflows, including staff education, workflow shadowing, audit-and-feedback activities, and optimization of electronic health record (EHR) use.

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; recruit study participants; act as intermediary between services and departments while overseeing data management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; manage Investigator's protocols in the IRB/Institutional Review Board 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.

Other responsibilities include supporting additional patient engagement activities outside of recruitment, including facilitating group education sessions (hybrid and in-person).

This position will need to travel to various clinic sites in-person across the Bay Area.

Department Description:

The UCSF Division of General Internal Medicine (DGIM) at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) delivers innovative, comprehensive and complex primary medical care to San Francisco's vulnerable patients; carries out highly impactful translational research focused on generating new knowledge to improve the health of vulnerable populations; engages in meaningful policy work focused on reducing health disparities and ensuring access to care; and trains the next generation of physician leaders and researchers in the care of vulnerable and underserved populations. DGIM works closely with the UCSF Action Research Center (ARC), which carries out innovative research to prevent and treat chronic disease in populations for whom social conditions often promote or make management of the chronic diseases more challenging. ARC is nationally and internationally known for its research in health communication and health policy to reduce health disparities, with special expertise in the social determinants of health, including literacy, food policy, poverty, and minority status, with a focus on the clinical conditions of pre-diabetes, diabetes, and cardiovascular disease.

Responsibilities

of time ( Nothing less than 5%)

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

55

YES
Study Coordination and Data Collection

• Identify participants, develop recruitment and retention strategies, and screen and enroll study participants.
• Schedule participants, for study visits; meet with them to administer questionnaires, collect medical history, and perform study procedures.
• Maintain rapport and relationships with participants, to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
• Obtain informed consent; review information with participants,; assess and advocate for patient safety throughout each protocol procedure.
• Oversee subject reimbursement; work to resolve discrepancies and issues.
• Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
• 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.

20

YES
Data management and reporting of results

• Collect data during participant visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
• Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
• Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Perform queries and analysis in databases.
• Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
• Maintain petty cash and vendor agreement forms.

5

Staff training

• 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.
• Attend and actively participate in regular team meetings
• Oversee data integrity, initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures
• Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
• Modify data collection instruments.
• Help schedule staff time and coordinate staff schedules.
• Maintain subject tracking systems.
• -Provide and coordinate orientations and training to new stakeholder advisors, facilitate stakeholder advisory council meetings, lead evaluation and feedback of advisory council meetings.

5

YES
Quality control procedures
5

YES
Study Implementation

5

YES

Protocol Submissions and Adherence

• Enter all existing and new study protocols into the Institutional Review Board (IRB) online system; seek assistance on maintaining all protocols in the system by communicating with IRB 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 IRB applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between IRB and study Investigators.
• Provide quality assurance checks to note if protocols or UCSF IRB applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

5

YES
Regulatory responsibilities

• Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Initiate and follow-up on IRB 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.

100%
(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

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Bilingual proficiency in written and oral communications in Cantonese and English or Spanish.
• 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.
• Basic knowledge of relevant policies and regulatory requirements. Basic knowledge of health professions education industry. Basic knowledge of administrative analysis and operations research. Skills in developing and implementing processes and systems. Familiarity with the administrative and operational implications in a program.
• Communication skills; includes verbal, written and active listening, empathy, humility, and warmth. Service oriented and responsive to questions and requests. Ability to interact in a professional, resourceful, and courteous manner. Ability to convey complex concepts in an understandable manner to a lay public.
• Demonstrated ability to develop working relationships study team as well as community/patient partners.
• Organizational and analytical skills, has ability to work with complex faculty calendars / schedules and requires well organized and detail-oriented precision.
• Investigative, data analysis, and reporting skills. Ability to generate computer reports, checking for errors, correcting and submitting accurate reports. Skills include entering, maintaining, extracting, and analyzing data in electronic systems.
• Familiarity and comfort with use of mobile phone apps, preferred knowledge of apps designed to promote wellness.
• Capacity for self-monitoring and improvement, demonstrated excellent punctuality, attendance, and reliability. Follow-up and works well under pressure and deadlines.
• Documentation skills, ability to set priorities, work collaboratively,
• Excellent computer and word processing skills, using standard software (such as Microsoft Word Excel, Access and/or PowerPoint).
• Proven flexibility to adjust to constantly changing priorities.
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Proactive in helping lead the development and implementation of recruitment strategies.

Preferred Qualifications:

• Bachelor's degree in health or public health or related discipline
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• At least one year of previous experience as a clinical research coordinator or equivalent combination of experience / training
• Experience with research tools such as REDCap, Qualtrics, Dedoose or Atlas.ti.
• Fluency in the usage of Institutional Review Board (IRB) online system for submission, renewal, and modification of protocols through this system.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience working with diverse populations, knowledge of community resources and experience working with a variety of community-based organization.
• 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: REDCap, Qualtrics, and Microsoft Excel.
• Experience applying the following regulations and guidelines:

Good Clinical Practice Guidelines

Health Information and Accountability Act (HIPAA)

The Protection of Human Research Subjects

IRB regulations for recruitment and consent of research subjects

Effective Cash Handling Procedures

Environmental Health and Safety Training

Fire Safety Training

About Us

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

The final salary and offer components are subject to additional approvals based on UC policy.

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

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