Clinical Research Program Manager

CDU University - LA
Charles R. Drew University of Medicine and Science
1731

E. 120th Street
Los Angeles, CA 90059, USA

Charles R. Drew University is located in the Watts-Willowbrook area of south Los Angeles and was founded in 1966 in the wake of the Watts uprising. CDU was founded to address inadequate medical care in the region and to provide equitable medical education opportunities for underrepresented students. CDU is strongly invested in the local and regional community. The university leads multiple partnerships and programs to provide equitable healthcare resources in a variety of south Los Angeles neighborhoods.

The Clinical Research Program Manager is responsible for the overall operational management of clinical research, trial, and study activities from design, set up, conduct, through closeout, and all administrative management duties. In this role, you will oversee the implementation of research activities for multiple studies. You will perform necessary tasks to manage projects and prioritize work to meet deadlines. You will plan and organize tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).

The Clinical Research Program Manager works closely with the Director, Principal Investigators (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to manage the administration of all aspects of studies, including compliant conduct, financial management, and adequate personnel support. This role includes supervision of research staff, coordination of resources, development of infrastructure, and implementation of strategies to expand the Center’s research capacity and impact.

• Provide daily administrative, regulatory, financial, and business activities necessary to assist investigators in the conduct of clinical research ves as a point of contact for all faculty and staff.
• Manage the day-to-day operations of the CTRC, including personnel supervision, scheduling, workflow management, and performance evaluation.
• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Scheduling of patients for research visits and procedures.
• Develop, implement, monitor, and maintain standard operating procedures (SOPs) to ensure efficient and compliant study conduct, while maintaining accurate source documents related to all research procedures.
• Track and report key performance indicators (KPIs) related to study volume, participant enrollment, sponsor satisfaction, and financial performance.
• Plan and coordinate strategies for increasing patient enrollment and improving clinical research efficiency.
• Develops, implements and maintains system records on employees, equipment inventories, and compliance activities, official minutes for required administrative leadership meetings.
• Develop and manage networks between an array of companies and organizations, including hospitals, pharmaceutical companies, government-based organizations, nongovernmental agencies, and clinical research organizations.
• Maintains competency and keeps up with trends and changes in regulations and developments in clinical research, disseminating information to appropriate departments.
• Supervises other research staff.

• Ensures site compliance with research protocols by reviewing regulatory requirements to confirm appropriate methods, practices, and procedures for all research activities.
• Ensure that all CTRC activities comply with FDA, ICH-GCP, NIH, HIPAA, and institutional policies.
• Oversee preparation and maintenance of regulatory documentation, study logs, and institutional correspondence.
• Schedules and maintains participant protocol activities while adhering to the study protocol schedule of assessments.
• Manages regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations.
• Communicates and collaborates on study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
• Provides ongoing quality control audits to ensure compliance with research protocols, including maintaining investigational drug accountability.
• Works closely with CDU’s Institutional Review Board (IRB) Administrator to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Interfaces with research participants to support eligibility assessment and informed consent according to protocol.
• Serve as the primary point of contact for regulatory inspections and sponsor monitoring visits.
• Supports the disbursement of investigational product and…