Part-Time Clinical Research Coordinator

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. Responsibilities include coordinating clinical research studies of varying size and complexity; identifying and screening eligible participants; coordinating recruitment, enrollment, informed consent, study visits, surveys, interviews, and other protocol-required procedures; and facilitating communication among investigators, clinical providers, research staff, participants, laboratories, and other departments. The CRC will collect, enter, validate, and manage research data and, as applicable, coordinate the collection, processing, tracking, and storage of research specimens. The CRC will 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. The CRC may manage study submissions through UCSF's Institutional Review Board (IRB) systems, including continuing reviews, reportable events, and study closures. Responsibilities may also include preparing and reviewing protocols, consent forms, recruitment materials, study instruments, standard operating procedures, and other study documentation; maintaining regulatory files; and supporting monitoring visits, audits, and regulatory reviews. The CRC may coordinate research activities with federal agencies, research networks, academic collaborators, industry partners, and other Hemophilia Treatment Centers and will 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. As part of the multidisciplinary HTC, the CRC will 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. The CRC will 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. Strict confidentiality and appropriate handling of protected health information and research data are required. Successful performance requires strong organizational and communication skills, attention to detail, and the ability to manage multiple priorities while maintaining protocol and regulatory compliance. The CRC will 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. Responsibilities

% of

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Function

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Supervisor) 40 YES Study Coordination and Data Collection 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.

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.

Assist patients as necessary with reading or computer-literacy deficits when using the self-administered web-based study tool to ensure as consistent a quality as possible in the responses.

Alert providers and social work staff to self-reported severe-depression/suicidality, ideally before appointment and always before the patient leaves clinic.

Clarify provider questions that may arise from these self-administered health surveys.

Conduct chartre views.

Implement study procedures according to approved Standard Operating Procedures (SOPs).

Other duties as assigned or required.

30 YES Data Management and Reporting of Results Collect data during subject visits; enter data from visits, and other subject-related participation into databases in a timely manner.

Create and maintain comprehensive data setsas requested by the CRM and/or PI.

Maintain datacollection forms foreffective data collection, entry, and analysis.

Respond to queries generated from sponsor database reviews

Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

Produce weeklyand monthly reports study progress

Interface with database managers around database issues and reporting.

Oversee data integrity; Adhere to study specific protocols and standard operating procedures and thoroughly document all study activities.

Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.

Document work flow and create/update protocols for training and grant-reporting purposes.

Attend and actively participate in regular team meetings.

Maintain subject tracking systems.

Other duties as assigned

30 YES Regulatory Responsibilities Assure studies are carried outaccording to Codeof Federal Regulations, Good Clinical Practice, and UCSF regulations.

Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.

Use sound judgment to maintain patientconfidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.

Participate in and cooperate with any internal and external auditsor reviews of study protocols; prepare necessary documentation.

Assist with renewal, modification, and submission of IRB applications and protocols.

100% (To

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The total sum should add up to 100%.) 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; 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.

HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training .

Proficiency in MS Word, Excel, and Outlook

Preferred

Qualifications:

Bilingual in Spanish and English

BA/BS degree

One year of experience in clinical research that includes sensitive content, or an equivalent combination of education and experience

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

Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.

Experience working with individuals with chronic health conditions in a service or research capacity

Experience working with electronic medical records.

Ability to understand priorities in clinical research

Willingness and ability to strictly follow approved study protocols and document all study activities

Highly organized, able to multi-task, and demonstrated success working in a fast-paced environment

Prior experience successfully establishing rapport with health care providers and staff

Excellent verbal and written communication skills

Record of excellent attendance and reliability

Ability to maintain patient confidentiality

A positive attitude and a sense of humor

Fluency in the usage of Institutional Review Board (IRB) online Iris system for submission, renewal, and modification of protocols through this system.

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.

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