Clinical Research Manager Jobs in San Francisco, CA

INTRODUCTION

The Clinical Research Coordinator (CRC) will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The CRC will coordinate various clinical studies on kidney disease patients. Duties include: enrolling patients in and assisting with execution of 1) industry trials for kidney disease; 2) enrollment of patients in biospecimen banking study from kidney disease clinic; 3) various smaller pilot studies in clinic 4) maintaining IRBs; and 5) other research studies as time permits. Responsibilities for all studies include: schedule patient visits and procedures; maintain accurate research charts and research study binders; perform accurate data collection and data entry; perform patient follow-up visits according to specific research study requirements; complete consent procedures and questionnaires with subjects; participate in research meetings; manage Investigator’s protocols in the Committee on Human Research (IRB) online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic 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 any internal and external audits or reviews of study protocols; and perform other duties as assigned. Also responsible for creating research accounts in Apex; linking patients to the research study and keeping their research status updated; linking encounters to the study and setting the research billing flag; creating lab orders and medication orders in Apex; scanning and uploading study consent forms into the patient’s medical chart; reviewing lab results, current medications, radiology studies, and providers’ progress notes for data collection into the research study database. The incumbent will also be required to create and maintain data entry accounts in Redcap and OnCore, the online data entry systems for research. Perform other duties as needed. There may be other opportunities to assist with other studies within the Division of Nephrology. If the incumbent is a certified phlebotomist, perform phlebotomy as needed.

BASIC QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

• 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