CLIN RSCH CRD

About the role

The Clinical Research Coordinator will perform independently or with general direction to execute, manage, and coordinate research protocols for rheumatic conditions such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and other rheumatology studies. This role involves coordinating multiple clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies.

Responsibilities

• Enroll patients in and assist with execution of industry trials (for industry and NIH), biospecimen banking studies, and smaller pilot studies in the clinic.
• Schedule patient visits and procedures; maintain accurate research charts and study binders.
• Perform accurate data collection, data entry, and patient follow-up visits according to study requirements.
• Complete consent procedures and questionnaires with subjects.
• Manage Investigator’s protocols in the Committee on Human Research (IRB) online system, including renewals, modifications, and implementation of new studies.
• Participate in the review and writing of protocols to ensure institutional review board approval within University compliance.
• Ensure compliance with all relevant regulatory agencies; oversee study data integrity and implement quality control procedures.
• Interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents.
• Report study progress to investigators; participate in internal and external audits or reviews of study protocols.
• Create research accounts in Apex; link patients to research studies and update their research status.
• Link encounters to the study, set research billing flags, and create lab and medication orders in Apex.
• Scan and upload study consent forms into patients’ medical charts.
• Review lab results, medications, radiology studies, and providers’ progress notes for data collection into research databases.
• Create and maintain data entry accounts in Redcap and OnCore, the online data entry systems for research.
• Perform phlebotomy if certified.
• Assist with other studies within the Division of Rheumatology as needed.

Requirements

• High school graduation and sufficient experience to perform the assigned duties and responsibilities.
• Attention to detail; strong interpersonal skills; excellent verbal and written communication skills.
• Ability 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 independently, complete projects in a timely manner, and prioritize multiple tasks to meet deadlines.

Preferred Qualifications

• Fluency in the usage of the Committee of Human Research (CHR) online iRIS IRB system for protocol submission, renewal, and modification.
• Understanding of patient population to create rapport and realistic expectations for patient participation.
• Experience with electronic medical records.
• Phlebotomy certification.
• Knowledge of UCSF and departmental policies for reimbursement, research guidelines, confidentiality, and HIPAA regulations.
• Knowledge of medical terminology, research policies, and guidelines for packing/shipping infectious substances.
• Experience with database building/analysis and data management in platforms such as Access, Stata, SAS/SPSS, and Teleform.
• Experience applying regulations and guidelines including Good Clinical Practice Guidelines, HIPAA, Protection of Human Research Subjects, CHR regulations, and safety training (e.g., Environmental Health and Safety, Fire Safety).