Part-Time Clinical Research Coordinator

About the Role

The Clinical Research Coordinator (CRC) will work independently or with general direction at the fully operational journey level to execute, manage, and coordinate clinical research activities 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 in accordance with approved protocols, UCSF policies, federal requirements, and applicable regulatory standards.

Key Responsibilities

• Coordinate clinical research studies of varying size and complexity.
• Identify and screen eligible participants.
• Coordinate recruitment, enrollment, informed consent, study visits, surveys, interviews, and other protocol-required procedures.
• Facilitate communication among investigators, clinical providers, research staff, participants, laboratories, and other departments.
• Collect, enter, validate, and manage research data.
• As applicable, coordinate the collection, processing, tracking, and storage of research specimens.
• Maintain study databases and tracking systems.
• Monitor data completeness and accuracy, respond to data queries, and implement quality-control procedures to ensure data integrity and regulatory compliance.
• May manage study submissions through UCSF's Institutional Review Board (IRB) systems, including continuing reviews, reportable events, and study closures.
• Prepare and review protocols, consent forms, recruitment materials, study instruments, standard operating procedures, and other study documentation.
• Maintain regulatory files.
• Support monitoring visits, audits, and regulatory reviews.
• Coordinate research activities with federal agencies, research networks, academic collaborators, industry partners, and other Hemophilia Treatment Centers.
• Help ensure compliance with Good Clinical Practice (GCP), federal regulations, UCSF and IRB requirements, study protocols, and sponsor requirements.
• 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.
• Collaborate with physicians, advanced practice providers, nurses, social workers, physical therapists, laboratory personnel, research staff, and other team members, as well as regional and national HTC partners and research networks.
• Interact with a diverse population of patients and families, including individuals managing complex chronic bleeding disorders, and must demonstrate professionalism, discretion, cultural humility, sensitivity, and a respectful, patient-centered approach.
• Maintain strict confidentiality and appropriate handling of protected health information and research data.
• Meet regularly with the PI, Clinical Research Manager, and HTC leadership to review recruitment and enrollment, data quality, regulatory requirements, study deliverables, and progress toward project milestones.

Requirements & Tech Stack

• MS Word, Excel, and Outlook proficiency.
• 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

Qualifications

• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions.
• 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.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Bilingual in Spanish and English (Preferred).
• BA/BS degree (Preferred).
• One year of experience in clinical research that includes sensitive content, or an equivalent combination of education and experience (Preferred).
• One year of volunteer or professional experience working in a clinic setting or equivalent e.g., community non-profit and interacting with patients / clients and their health care providers (Preferred).
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation (Preferred).
• Experience working with individuals with chronic health conditions in a service or research capacity (Preferred).
• Experience working with electronic medical records (Preferred).
• Ability to understand priorities in clinical research (Preferred).
• Willingness and ability to strictly follow approved study protocols and document all study activities (Preferred).
• Highly organized, able to multi-task, and demonstrated success working in a fast-paced environment (Preferred).
• Prior experience successfully establishing rapport with health care providers and staff (Preferred).
• Excellent verbal and written communication skills (Preferred).
• Record of excellent attendance and reliability (Preferred).
• Ability to maintain patient confidentiality (Preferred).
• A positive attitude and a sense of humor (Preferred).
• Fluency in the usage of Institutional Review Board (IRB) online Iris system for submission, renewal, and modification of protocols through this system (Preferred).
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPAA 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, database building/analysis, and data management within some of the following: REDCap (Preferred).