Charles R. Drew University of Medicine and Science · 1 day ago
Clinical Research Program Manager
Los Angeles, CA
Full-time
Onsite
Senior Level
$76K/yr - $90K/yr
5+ years expCharles R. Drew University of Medicine and Science is a mission-driven institution focused on providing equitable healthcare resources and education. The Clinical Research Program Manager will oversee the operational management of clinical research activities, ensuring compliance with regulations and protocols while managing research staff and resources.
Higher Education
Responsibilities
Provide daily administrative, regulatory, financial, and business activities necessary to assist investigators in the conduct of clinical research at CDU. Serves 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
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 while adhering to study protocol schedule of assessments
Manages the regulatory staff in the maintenance of regulatory documents in accordance with SOP and applicable regulations
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Ensures compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing 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 efforts to determine eligibility and consenting of study participants according to protocol
Serve as the primary point of contact for regulatory inspections and sponsor monitoring visits
Supports the disbursement investigational product and provides patient teaching regarding administration, as necessary
Identifies and prioritizes the development of systems and infrastructure to maintain research quality and compliance
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings
Notifies direct supervisor about concerns regarding data quality and study conduct
Validates large subsets of clinical patient data
Assists with designing database/data architecture transitions
Qualification
Required
Bachelor's Degree from an accredited institution in life sciences (biology, chemistry, microbiology), health sciences, public health, clinical research administration, or medical technology required
5 years of progressively responsible experience in clinical research, including at least 3 years in management or supervisory roles required
Grant administration and operations experience is required
3 years' experience managing the day-to-day operations of clinical trials, research programs, data management, and computer/related systems is required
Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
Ability to use discretion and maintain privacy, confidentiality or anonymity
5 or more years of direct staff management experience, including recruitment and training, is preferred
Experience managing multi-site, NIH, or industry-funded studies
Experience developing and communicating detailed, technical-scientific, and administrative program information to various audiences in written and oral form
Proven ability to manage budgets, contracts, and personnel effectively
Ability to work independently as well as communicate well with other professionals
Strong written and verbal communication abilities and highly effective interpersonal skills
Ability and/or experience supervising and training employees, including organizing, prioritizing, and scheduling work assignments
Excellent customer service skills
Current knowledge of GCP principles, HIPAA, compliant research conduct, and guidelines surrounding human subject research
Proficiency in Microsoft Office Suite and electronic data capture systems (e.g., REDCap, OnCore)
Conflict resolution experience with the ability to multitask, collaborate and prioritize
Possess effective leadership abilities
Coaching/teaching abilities
Ability and/or experience managing budgets, preferably research project budgets
Preferred
Master's Degree Preferred
5 or more years of direct staff management experience, including recruitment and training, is preferred
Strongly prefer experience and knowledge in the Biological Sciences, Health, and Health Disparities
Company
Charles R. Drew University of Medicine and Science
Charles R. Drew University of Medicine and Science (CDU) is a private, nonprofit, nonsectarian, medical and health sciences institution.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$0.8MKey Investors
ConstellationThe California Endowment
2025-11-20Grant
2019-12-13Grant· $0.8M
Leadership Team
Bita Amani
Co-Founder and Co-Director, CDU Black Maternal Health Center of Excellence
Brandi Sims Desjolais, Ed.D
Co-Founder & Director, Black Maternal Health Center of Excellence
Recent News
2025-03-05
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