Part-Time Clinical Research Coordinator

UCSF•San Francisco, CA

5d•$40 - $45•Onsite

About The Position

The Clinical Research Coordinator (CRC) works independently or with general direction at the fully operational journey level to execute, manage, and coordinate clinical research within a federally funded Hemophilia Treatment Center (HTC) at UCSF. Under the direction of the Clinical Research Manager (CRM), Principal Investigator (PI), and/or other designated leadership, the CRC may coordinate multiple concurrent studies involving adults with hemophilia, von Willebrand disease, and other bleeding disorders, following approved protocols, UCSF policies, federal requirements, and applicable regulatory standards. Research activities may include clinical trials, observational studies, registries and surveillance programs, patient-reported outcomes, surveys, interviews, and other clinical or health-services research focused on improving the health, treatment, and quality of life of adults with inherited bleeding disorders. The CRC coordinates recruitment, screening, enrollment, informed consent, study visits, protocol procedures, data collection and management, and—when applicable—research specimen collection and tracking. The role may also involve IRB submissions, regulatory documentation, quality-control activities, monitoring visits, audits, and collaboration with federal agencies, research networks, academic collaborators, industry partners, and other HTCs. As part of the multidisciplinary HTC, the CRC collaborates with clinicians, research staff, laboratories, departments, and regional and national partners. The role involves interacting with a diverse patient population and families, including people managing complex chronic bleeding disorders, with professionalism, discretion, cultural humility, sensitivity, and a respectful, patient-centered approach. Strict confidentiality and appropriate handling of protected health information and research data are required. The CRC meets regularly with the PI, CRM, and HTC leadership to review recruitment and enrollment, data quality, regulatory requirements, study deliverables, and progress toward milestones.

Requirements

High school graduation and sufficient experience and demonstrated skills to perform the assigned duties and responsibilities, or equivalent experience or training.
Attention to detail and strong interpersonal skills.
Excellent verbal and written communication skills for coordinating with participants, team members, departments, and outside institutions.
Ability to multitask in a fast-paced environment while working with a diverse participant population.
Ability to work independently, complete projects in a timely manner, and prioritize multiple projects to meet deadlines.
Proficiency in Microsoft Word, Excel, and Outlook.

Nice To Haves

Bilingual in Spanish and English.
Bachelor of Arts or Bachelor of Science degree.
One year of clinical research experience involving sensitive content, or an equivalent combination of education and experience.
One year of volunteer or professional experience in a clinic setting or equivalent, such as a community nonprofit, interacting with patients or clients and their healthcare providers.
Understanding of the patient population and ability to build rapport while assessing what is realistic and appropriate for participant involvement.
Experience working with individuals with chronic health conditions in a service or research capacity.
Experience with electronic medical records.
Ability to understand priorities in clinical research.
Willingness and ability to follow approved study protocols strictly and document all study activities.
Strong organization and multitasking skills, with demonstrated success in a fast-paced environment.
Prior experience establishing rapport with healthcare providers and staff.
Excellent verbal and written communication skills.
Excellent attendance and reliability.
Ability to maintain patient confidentiality.
Positive attitude and sense of humor.
Fluency using the IRB online Iris system for protocol submissions, renewals, and modifications.
Knowledge of UCSF and departmental policies on reimbursement, research guidelines, confidentiality, HIPAA, patient safety, medical records, and research; familiarity with medical terminology, research policies and guidelines, database building and analysis, and data management tools such as REDCap.
Experience applying Good Clinical Practice Guidelines, HIPAA, protections for human research subjects, CHR regulations for research recruitment and consent, effective cash-handling procedures, Environmental Health and Safety training, and fire safety training.

Responsibilities

Identify, recruit, screen, and enroll eligible study participants; develop recruitment and retention strategies.
Schedule study visits and conduct questionnaires, medical-history collection, interviews, and other protocol-required procedures.
Obtain informed consent, explain study information, and advocate for participant safety throughout protocol procedures.
Maintain participant relationships, communication, retention, and follow-up; act as an intermediary and discuss study outcomes with providers to support continuity of care.
Oversee participant reimbursement and help resolve discrepancies or issues.
Coordinate scheduling and communication with other studies, technicians, affiliated groups, investigators, clinical providers, research staff, laboratories, departments, and external collaborators.
Review medical charts and electronic records and extract information for research studies.
Assist participants with reading or computer-literacy needs when using self-administered web-based study tools; clarify provider questions about survey responses.
Alert providers and social work staff to self-reported severe depression or suicidality, ideally before appointments and always before participants leave the clinic.
Conduct chart reviews and implement study procedures according to approved standard operating procedures (SOPs).
Collect, enter, validate, analyze, and manage study data; maintain comprehensive datasets, data-collection forms, databases, and participant tracking systems.
Monitor data completeness, accuracy, and integrity; respond to sponsor database queries and coordinate with database managers on database issues and reporting.
Produce weekly and monthly study-progress reports and maintain data and study documentation in a timely and thorough manner.
Maintain and update procedure manuals, workflows, protocols, and training and grant-reporting documentation; help ensure consistent data collection and entry.
Attend and actively participate in regular team meetings.
Maintain regulatory documents and timelines; document adverse events and submit them to appropriate departments.
Assist with IRB applications and protocol submissions, renewals, modifications, continuing reviews, reportable events, and study closures, as applicable.
Ensure studies comply with the Code of Federal Regulations, Good Clinical Practice, UCSF and IRB requirements, approved protocols, and sponsor requirements.
Maintain participant confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
Prepare documentation for and participate in internal and external audits, monitoring visits, and reviews of study protocols.
Perform other duties as assigned or required.