Clinical Research Program Manager

Mission Driven, Community Focused About | Charles R. Drew University of Medicine and Science (cdrewu.edu)

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.

Job Summary:

The Clinical Research Program Manager is responsible for the overall operational management of clinical research, trial, study activities from design, set up, conduct, through closeout, and all administrative management duties. In this role, you will be responsible and oversee the implementation of research activities for multiple studies. Perform necessary tasks to manage projects and prioritize work to meet necessary deadlines. You will be responsible for planning and organizing necessary 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, but not limited to, 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.

Essential Duties and Responsibilities:

Administrative Responsibilities

• 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.
• Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.

• Develops, implements and maintains system records on employees, equipment inventories, and compliance activities, official minutes for all 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, both internally and externally. Ensures information is disseminated to appropriate departments.

• Supervises other research staff.

Clinical and Compliance Oversight

• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of 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…