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. Job Summary 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. Essential Duties and Responsibilities Administrative 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. 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. Clinical and Compliance Oversight 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 provides patient teaching regarding administration, as necessary. Communicates and collaborates with study teams, including internal and external parties, sponsors, PI, and study participants. Data and Quality Management Identify and prioritize 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. Validate large subsets of clinical patient data. Assist with designing database/data architecture transitions. Qualifications Education Bachelor's Degree from an accredited institution in life sciences (biology, chemistry, microbiology), health sciences, public health, clinical research administration, or medical technology required. Master’s Degree preferred. Experience 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. Strongly prefer experience and knowledge in the Biological Sciences, Health, and Health Disparities. Knowledge/Ability/Skills 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. 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. Compensation $75,700 - $90,000 annual Position Status Full Time, Exempt Complexity The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position. The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position. Demonstrated competencies in strategic and systems thinking, project management, and knowledge of continuous improvement methods. Ability to manage various projects and assignments with multiple priorities in a rapidly changing environment. Experience with Center development/expansion, including in scientific areas, student training, clinical research areas, and community-based areas, as well as related grant proposal development, writing, and submission to federal agencies or foundations. Ability to develop and maintain professional working relationships in complex program/organizational settings involving heterogeneous constituents such as academic and clinical faculty, staff, students, and community partners from diverse backgrounds. Experience interpreting operating policies, and procedures, resolving minor discipline and other employee relations issues within an academic setting or institution. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasional stooping. Frequent standing. Constant walking, sitting, climbing, reaching high/low levels, finger movement, feeling, speaking clearly, hearing conversationally, and seeing far and near. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasionally required to work in confined space. Position is on-site unless specific authorization from the manager. Mental Demands The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Frequent work on a variety of unrelated tasks. Constant calculating interrupted work, work on a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity. Special Requirements Ability to work effectively with a diverse community. Conditional Employment The employment status of this position is classified as “Conditional.” Conditional employment means that the job exists contingent upon continued funding and limitations of restricted funds or, the duration of a specific program, project, grant, or contract. Since your salary is funded by Axis CTRC and Novartis Grant(s) and 2/28/2026, your position is contingent upon the continued receipt of these funds. Continuation of your position is dependent, in part, upon funding availability. Furthermore, no work may be performed after the grant end date(s) unless you have received an extension in writing from a Dean, Division VP, or Human Resources. EEO Statement: Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability or covered veteran status. Fair Chance Statement: Charles R. Drew University of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws. Note Qualifications, Skills, Motivations, Education, Experience, and Licenses & Certifications sections appear with structure intended for posting; some headings may be redundant. Ensure final posting presents a clean, consistent hierarchy. #J-18808-Ljbffr Cdrewu