Description

Clinical Research Team Supervision 

Under mentorship, ability to supervise and provide guidance to direct reports in a positive and motivating manner. Under mentorship, handle employee relations and human resources issues. Assign work to team members, assessing workload and shifting as required to meet the goals of the department. Ability to develop succinct reports demonstrating metrics of team and report to leadership. Financial oversight of unit budget. Support ongoing and career development of subordinates. Onboard and train clinical research coordinators, ensuring adherence to all applicable policies. Responsible for team’s output and work.

Clinical Research Coordination 

Assigns study assignments to lower level clinical research coordinators and provides guidance. Serves as resource for department or unit. Resolves complex and high volume clinical research study coordination and portfolios. Independently manage a portfolio of studies including complex studies such as multi-center clinical trials and/or investigator-initiated trials. Utilizes independent judgement to determine the most appropriate and efficient method of completing work and projects. Independently identifies issues and proactively troubleshoots with investigators, sponsors and internal partners to ensure they are addressed. Analyzes problems / issues of highly complex scope and determines solutions. Develops and implements recruitment and retention strategies. Provides financial queries and supports UCLA required clinical trial functions such as OnCore data entry, response to financial queries, request and review of Beacon/non-cancer order templates, etc. Manages and resolves sensitive patient and customer services related issues, providing guidance to staff as needed. Establishes and schedules study start-up dates and assignments. Coordinates research studies, including proactive identification of participants and supporting the PI in determining patient eligibility with limited guidance. Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility. Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance. Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source. Manages patient registration, data and treatment assignment. Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection & shipping biospecimens. Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice. Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source). Completes other tasks as assigned. As a part of the larger clinical research team, assists colleagues as needed and as possible while ensuring that own work is completed and prioritized.

Data and Regulatory Management

Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable. Prepare and submit site or study-specific regulatory documents. Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders. Ensure timely regulatory reporting and thorough documentation.   Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed.

Training and Development

Provides training and oversight for developing clinical research coordinators – mentors developing clinical research coordinators to work independently and critically think through issues and challenges. Completes role-based training and occupational training as applicable, e.g. blood borne pathogens, infection control, hand hygiene, donning and doffing PPE. Attend study initiation meetings, and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). Completes protocol required training as needed.

Service Excellence

May lead activities around quality improvement, SOPs, formulating strategy, processes, etc. Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated. Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request. Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support.

Other Duties as Assigned

This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.