The Southern California Clinical and Translational Science Institute (SC CTSI) is a multifaceted resource for clinical and community-partnered translational research. Clinical Research Support (CRS) is a core group within SC CTSI that provides expertise and support for clinical research operations, services and resources to make the conduct of clinical research efficient, safe, streamlined and compliant. Among those services is a pool of clinical research coordinators (CRCs) that are contracted to various investigators at USC and Keck to support the conduct of non-cancer human studies.
We are seeking an experienced CRC Supervisor to oversee the day-to-day activities of the clinical research coordinator pool and related services including IRB and multisite studies support. The CRC Supervisor will work closely with program leadership, CRS staff and other core groups as needed to implement and manage the essential operations of the CRS group.
The Supervisor will assist CRS leadership with special projects as needed. The proportion of effort devoted to each component can change at any time depending on business needs.
Clinical Research Coordination: Relevant skills include superb organization, attention to detail, thorough knowledge of research compliance, effective participant recruitment skills, regulatory document preparation, data entry and management, and 5+ years of clinical research coordination experience.
Communication: Excellent communication is needed to ensure collaboration and execution across a wide range of University offices and staff as well as amongst stakeholders. Must be able to articulate concepts and information clearly to various audiences including investigators, research coordinators, administrators and other research-related personnel. Must be able to work with SC CTSI leadership team including CRS Director and Associate Director; Operations, Finance and HR leadership, CTSI Directors, and other core groups.
Personnel Management: Strong personnel management skills required; proven track record of successfully managing a medium to large team of direct reports is necessary to ensure effective staffing allocation, high-quality coordinator support, and sustain PI satisfaction over the course of the research project.
Project Management: Strong project management skills required to navigate complex operational processes, drive projects forward and adhere to program deadlines.
Collaboration: Strong history of collaboration reflective of the strong collaborative climate between programs at SC CTSI necessary to achieve institutional goals; ability to work successfully with department administrators, project managers and other personnel to carry out program goals.
Anticipates needs for hiring new coordinators and collaborates with HR during job posting process.
Recruits, hires and interviews new research coordinators, and places them onto incoming studies.
Onboards and trains new coordinators.
Serves as point of contact for all questions from coordinators.
Ensures compliant research conduct amongst coordinator staff throughout the lifecycle of the study assignment.
Conducts initial meeting with new PI(s) and study staff; ensures coordinator is acclimated to study and responsibilities.
Fills in for study-related tasks when necessary and other coordinators are unavailable to provide coverage.
Manages team of clinical research coordinators and their daily study-related responsibilities, ensures proper staffing allocations and effort utilization on a monthly and ongoing basis.
Tracks coordinatorsâ effort utilization; projects and plans for their ongoing research engagements, and ensure coordinatorsâ efforts and workload are manageable
Designs and implements opportunities for career advancement, ongoing professional development and education for coordinator staff.
Builds team morale through staff meetings, team building events and more.
Assesses coordinators performance and evaluates PI satisfaction; delivers timely feedback and support and develops plan for improvement if needed.
Serve as the liaison between coordinators and PI/study teams. Troubleshoot personnel issues amongst PI/staff and coordinators.
Assists Director and Associate Director in promotional efforts, such as roadshows, departmental meeting presentations, seminars and other events. Helps to advertise availability of CRC-related services when appropriate.
Identifies upcoming research engagements for coordinators to work on.
In collaboration with the Research Navigator, provides individualized consultations to best assist investigators and other research personnel to conduct high-quality, efficient, compliant research.
Covers for CRS-related duties of Research Navigator and/or Associate Director when they are unavailable.
Works with other SC CTSI core groups to promote, catalyze and support collaborative cross-disciplinary teams and projects.
Provides administrative and programmatic support to program-related meetings.
Assists CRS Director with projects related to increasing the quality and efficiency of all aspects of clinical research support.
Provides ongoing education to coordinators regarding audits/monitoring visits from industry sponsors; preparing and writing progress reports for federally funded studies.
Trains coordinators on how to use relevant study-related software or CTMS tools such as iStar, OnCore, REDCap, cohort discovery tools, and other EDCs in an effective and compliant manner.
Performs audits of studies and study-related source documents and data for studies supported by CTSI coordinators to ensure quality control; retrains coordinators as needed.
Trains coordinators serving as monitors for internal quality control purposes. Assigns monitors to studies within CRS to ensure compliant conduct, data quality and safety.
Assists coordinators in handling issues with accommodating drugs at study pharmacy and Investigational Drug Services pharmacy. Collaborates with pharmacists to maintain accurate accountability of investigational products, specimens and study drugs.
Develop, implement and oversee IRB staff services and support staff. Collaborate with central IRB office on study team needs and areas CRS can support.
Supervises preparation and submission of adverse event reports to IRB; helps coordinators with preparation and submission of continuing review.
Oversees preparation of study documents such as IRB applications, informed consent, recruitment scripts, and other materials. Assists with training coordinators on regulatory preparation and submission.
Promote IRB services among researchers and coordinators
Provides high-quality writing and regulatory support to study teams submitting proposals for multicenter study opportunities.
Serves as the administrator and point of contact for disseminating information about multicenter study opportunities to faculty;
Collaborates with CHLA to ensure timely multicenter study activitation and implementation.
Other duties as assigned.
Minimum Education: Master's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 5 years, Combined education/experience as substitute for minimum experienceMinimum Field of Expertise: Certified research coordinator. Administrative or research experience. Knowledge of medical environment and terminology. Knowledge and understanding of federal, state, and institutional research regulations including Good Clinical Practices (GCP) and HIPPA regulations. Budget control and development experience. Proficient with MS Office applications. Demonstrated effective communication and writing skills. Ability to multi-task and prioritize. Demonstrated ability to work as part of a team as well as independently. Knowledge of Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
Internal Number: REQ20083779
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