Mgr, Clin Research Operations

Description

Title: Manager of Clinical Operations

Location: MemorialCare Shared Services, Fountain Valley

Department: Research Administration

Status: Full Time

Shift: Days (8hr)

Pay Range*: $62.63/hr. – $93.95/hr.

MemorialCare is a nonprofit integrated health system that includes four leading hospitals, award-winning medical groups – consisting of over 200 sites of care, and more than 2,000 physicians throughout Orange and Los Angeles Counties. We are committed to increasing access to patient-centric, affordable, and high-quality healthcare; your personal contributions are integral to MemorialCare's recognition as a market leader and innovator in value-based and other care models.

Across our family of medical centers, we support each one of our bright, talented employees in reaching the highest levels of professional development, contribution, collaboration, and accountability. Whatever your role and whatever expertise you bring, we are dedicated to helping you achieve your full potential in an environment of respect, innovation, and teamwork.

Position Summary

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).

Essential Functions and Responsibilities of the Job

• 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.

*Placement in the pay range is based on multiple factors including, but not limited to, relevant years of experience and qualifications. In addition to base pay, there may be additional compensation available for this role, including but not limited to, shift differentials, extra shift incentives, and bonus opportunities. Health and wellness is our passion at MemorialCare—that includes taking good care of employees and their dependents. We offer high quality health insurance plan options, so you can select the best choice for your family. And there’s more...Check out our for more information about our Benefits and Rewards.

Qualifications

Minimum Requirements

Qualifications/Work Experience:

• 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.

Education/Licensure/Certification:

• Bachelor’s Degree in a scientific or related health care field required.

• ACRP-CCRC and/or SOCRA CCRP preferred.