Clinical Research Coordinator

UCSF•San Francisco, CA

About The Position

The Clinical Research Coordinator (CRC) will support two concurrent clinical trials: a pilot RCT of psilocybin-assisted therapy for methamphetamine use disorder in people living with HIV and an ongoing Phase III trial of LSD for Major Depressive Disorder. The effort will be split 50% between Neuroscape/Neurology and 50% between UCSF-ZSFG Division of General Internal Medicine. The 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). They will coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF, and regulating agency policies.

Requirements

Support two concurrent clinical trials: a pilot RCT of psilocybin-assisted therapy for methamphetamine use disorder in people living with HIV (NIDA-funded, NoA pending, active IND with Schedule I substance requirements) and an ongoing Phase III trial of LSD for Major Depressive Disorder (accounting for the Medicine/Neurology split).
Effort will be split: 50% Neuroscape/Neurology and 50% UCSF-ZSFG Division of General Internal Medicine.
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).
Coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Responsibilities

Support the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity.
Act as an intermediary between services and departments while overseeing data and specimen management.
Manage and report on study results.
Create, clean, update, and manage databases and comprehensive datasets and reports.
Coordinate staff work schedules, recruit and train Assistant CRCs for the research team, and assist the Clinical Research Supervisor and/or PI with oversight of other research staff.
Manage Investigator’s protocols in the Committee on Human Research 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.
Perform other duties as assigned by the PI.