Part-Time Clinical Research Coordinator

UCSF Health, AG; San Francisco (CA); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

UCSF Health seeks a Clinical Research Coordinator to independently manage and coordinate clinical studies within a federally funded Hemophilia Treatment Center. You will support adults with bleeding disorders, ensure protocol adherence, and liaise with investigators, providers, and laboratories under CTRM/PI supervision.

The role emphasizes data integrity, regulatory compliance, and effective communication across departments to advance patient care and research outcomes.

Competenze

• Attention to detail and strong interpersonal communication to coordinate with subjects, team members, and outside institutions.
• Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced research environment.
• HS graduation with sufficient experience or equivalent training.
• Proficiency in MS Word, Excel, and Outlook.

Mansioni

• Coordinate clinical research studies of varying size and complexity.
• Identify and screen eligible participants and manage enrollment, consent, and study visits.
• Maintain study databases, validate data, and respond to data queries.
• Coordinate IRB submissions, continuing reviews, and study closures as applicable.
• Assist with preparation of protocols, consent forms, and regulatory documents.
• Collaborate with physicians, nurses, research staff, and external partners to ensure regulatory compliance.

Conoscenze

Attention to detail

Strong communication

Independent work

Multi-tasking

Data management

Formazione

HS graduation

BA/BS degree preferred

Strumenti

MS Word

MS Excel

Outlook

Descrizione del lavoro

Job Description

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.

Job Description

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.

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