Clinical Research Program Manager

Mission Driven Community FocusedAbout Charles R. Drew University of Medicine and Science ()

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 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 Centers 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.
• 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 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 CDUs 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.
• 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

• Bachelors Degree from an accredited institution in life sciences (biology chemistry microbiology) health sciences public health clinical research administration or medical technology required. Masters 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.
• 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.

Compensation:

• $75700 - $90000 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 themanager.

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.

Required Experience:

Manager