Mgr, Clin Research Operations

MemorialCare•Fountain Valley, CA

9d•Onsite

About The Position

Under the direction of the Clinical Operations Director of Research Administration, the Research Clinical Operations Manager is accountable for the leadership efforts of the Office of Research Administration as it relates to the research program of MemorialCare Health Systems. The responsibilities are broad and diverse to include personnel management, physician relations, customer service, oversight of study patient screening and enrollment, tracking of clinical trial progress, compliance with regulatory standards, and the general oversight of the research process. This position is responsible for the direct oversight of the research staff and for the performance of staff members when involved in research (e.g., Regulatory Affairs Coordinators, department secretaries, and clinical staff such as coordinators, technicians, service line liaisons, and practitioners).

Requirements

5 years of experience in a Clinical Research Operations preferred.
Management and leadership experience in Clinical Research Operations, research or a related health care field.
Knowledge of research design, research process, study budgets and study implementation.
Strong leadership, planning and project managements skills.
Thorough understanding of FDA, GCP, and ICH guidelines.
Thorough understanding of research compliance requirements.
Outstanding verbal and written communication skills.
Bachelor’s Degree in a scientific or related health care field required.

Nice To Haves

ACRP-CCRC and/or SOCRA CCRP preferred.

Responsibilities

Establish, evaluate, and oversee clinical and administrative operations, regulatory compliance, policies and procedures training and education for the Office of Research Administration Clinical Operations Division.
Hire, orient, train, and conduct performance reviews for clinical operations teams responsible for handling research activities associated with conducting of clinical trials.
Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
Manages and provides direction and leadership to clinical operations teams; responsible for the oversight and monitoring of all MHS clinical trials.
Supervise the implementation of and adherence to study protocols.
Educate research staff on established policies, processes, procedures and good clinical practice.
Work the team to determine effective strategies for recruiting participants and retaining participants in clinical trials.
Monitor recruitment goals for all studies and adjust as necessary to meet goals.
Analyze trends in recruitment and assure there is a limited number of competing trials.
Audit operations to ensure compliance with applicable GCP and federal regulations; Develop quality performance metrics in order to identify opportunities for improvement.
Execute education and corrective action plans.
In collaboration with the finance manager, assist with any inquiries associated with clin ops costs contained within clinical trial budgets.
Identify and communicate study related concerns and potential solutions to senior leadership as needed.
Facilitate and implement solutions with the research team.
Develop/enhance metrics to present significant research efforts, findings, outcomes, and approvals internally and to external audiences.
Utilize critical insight and available resources to evaluate and select research studies in conjunction with the Executive Director of Research Administration and the associated Principal Investigator.
Provide general leadership in relation to each individual trial and effectively collaborate with other departments to meet all timelines and goals.
Ensure policies and procedures are in place for all new research studies. Additionally, perform routine updates as needed to existing policies and procedures.
Assure all aspects of research are compliant with regulatory and study standards.
Fosters collaborative relationships with other departments, entities and community organizations to facilitate and support the mission, vision, and goals of research.
Utilizes collaborative communication techniques to achieve positive outcomes in all interactions.
Effectively manages change processes as they impact research operations and staff.
Presents to work on time, follow organization rules, policies, procedures and directives.
Effectively interacts with staff in a positive and constructive manner.
Ability to make suggestions for enhancements throughout the department and continually seeks opportunities to improve current policies, procedures and practices while prioritizing the tasks assigned.