Clinical Research Program Manager

Clinical Research Program Manager

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, 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.

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 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.
• 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.
• 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: $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. 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: 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: Occasionally required to work in confined space. Position is on-site unless specific authorization from the manager.

Mental Demands: Frequent work on a variety of unrelated tasks. Constant calculating interrupted work,