Clinical Research Coordinator - GI Division

UCSF Health is seeking a Clinical Research Coordinator to support the GI Division’s clinical research studies involving liver disease, liver transplantation, and HCV care. The role coordinates study operations, participant recruitment and consent, specimen collection, data and regulatory management, quality control, and mobile outreach activities, including driving a university van and performing HCV testing procedures.

Responsibilities

Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects

Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures

Maintain rapport and relationships with subjects 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 subjects; 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

Set up approved studies in APEX and OnCore, identify all study subjects in APEX to ensure research related expenses are billed to the study and that the patient’s insurance is billed for standard of care expenses

Review APEX work queue on a daily basis, resolve incorrect patient billing issues

Identify non-standard of care patient care costs and procedures related to the study, complete a monthly invoice form and provide it to the research finance analyst (RFA) for payment from the sponsor

Prepare check requests for participation in the study as well as for issuing reimbursement for travel, as stipulated in the consent form

Follow designated procedures as described in the individual study protocols using aseptic techniques and ensuring participant safety during the phlebotomy process

Follow designated procedures as described in the individual study protocols for specimen collection using urine samples and finger pricks

Arrange the exchange of and transport of specimens with collaborating Investigators and staff

Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications

Ensure integrity and security of samples

Maintain temperature logs

Maintain and organize -80 freezers

Maintain Cyro Storage

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

Collect data during subject 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

Study Implementation

Data management

Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR 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 CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators

Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed

Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations

Initiate and follow-up on CHR 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

Responsible for driving the university van to and from outreach shifts and vehicle maintenance services

Preferred

Phlebotomy certification

Having experience performing phlebotomy with people experiencing homelessness and people who inject drugs is preferable

BA or BS in physical or biological sciences and one year of clinical research experience

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

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

Experience working with programs serving people experiencing homelessness and/or substance dependence

Phlebotomy Certification

Phlebotomy Experience

Homelessness-Sensitive Care

Substance Use Population Experience

Physical Sciences Degree

Biological Sciences Degree

Clinical Research Experience

iMEDris

Research Protocol Submission

Protocol Renewal

Electronic Medical Records

UCSF Policy Knowledge

Research Policy Knowledge

Reimbursement Procedures

HIPAA Compliance

Patient Safety

Medical Record Confidentiality

Medical Terminology

Infectious Substance Shipping

Database Building

Data Analysis

Data Management

Microsoft Access

Stata

SAS

SPSS

Teleform Programming

Clinical Practice

Human Research Protection

Research Recruitment

Informed Consent

Cash Handling

Environmental Health

Fire Safety

Homelessness Services Experience

Substance Dependence Services Experience

Rapport Building

Patient-Centered Judgment

Company

Integrated hospital and health care network

San Francisco, California, USA

https://www.ucsfhealth.org/

Founded in 1990

5001-10000 employees

Qualifications

The Clinical Research Coordinator is required to be experienced in research with “hard-to-reach” and vulnerable populations, knowledge of resources for HCV and HIV prevention and education, drug abuse prevention and treatment, and street and community-based outreach methods

California Driver's License

High Schol Diplima; 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

Phlebotomy certification

Having experience performing phlebotomy with people experiencing homelessness and people who inject drugs is preferable

BA or BS in physical or biological sciences and one year of clinical research experience

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

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

Experience working with programs serving people experiencing homelessness and/or substance dependence

Required skills

Clinical Research, California Driver’s License, Committee on Human Research (CHR) iMEDris, Electronic Medical Records, Clinical Practice (GCP), HIPAA, Human Subjects Research Protection, HCV and HIV Prevention, Street and Community-Based Outreach, Phlebotomy, Database Management and Analysis, Microsoft Access, Stata, SPSS, SAS, TeleForm

Preferred skills

Phlebotomy certification, Experience with electronic medical records, Good Clinical Practice Guidelines, Health Information and Accountability Act (HIPAA), The Protection of Human Research Subjects, Effective Cash Handling Procedures, Environmental Health and Safety Training, Fire Safety Training, San Francisco, California, USA, https://www.ucsfhealth.org, Late Stage, Leadership Team, Elizabeth Engel, Executive Director - UCSF Health Converge, Mitchell Rosen, UCSF, Assistant Professor, Recent News, TechTarget, OpenAI launches Epic integration with ChatGPT for Healthcare, 2026-09-03, Bizjournals.com Feed (2025-11-12 15:43:17), 2026-07-17, HealthCareIT News, 2026-04-08, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out

Experience

Mid level