Director, Clinical Research Ops
Company: MemorialCare
Location: Fountain Valley
Posted on: June 18, 2022
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Job Description:
Under the direction of the Executive Director, the Director of
Research Clinical Operations is responsible for providing overall
administrative leadership, business development and operational
management of the MemorialCare Health System research program as
well as the associated quality and administrative functions of the
clinical research activity. The Director will oversee all aspects
of research conducted at MHS including seeking out clinical trial
opportunities, collaborating with the Principal Investigators to
support their research endeavors, coordinating all study
information and activities, and working with physicians/clinicians
and external research companies to differentiate the MHS research
program.
The Director is expected to emphasize appreciation and
responsibility for research compliance, collaboration among
research disciplines, investigator engagement, the support for a
clinical trial management software solution, as well as
strategizing for new business and pipeline development
opportunities, generating a positive return on investment related
to project-specific research endeavors, and building a culture of
robust clinical trial integration throughout our MemorialCare
Health System.
Principal Duties and Responsibilities:
Programmatic Direction
Provide oversight for the day-to-day clinical research operations
in conjunction with the Executive Director of MHS Research;
determining the short and long-term vision for MHS Research
Direct the clinical research operational requirements of the
department and ensure efficiency and effectiveness in the
activities of clinical operations so that resources are used to
assist in achieving the goals of the department
Maintain liaison with the MHS research community and work in
collaboration with Executive Director and senior leadership to
request support and problem solve
Direct the overall distribution of research trial support,
system-wide
Develop the overall pipeline development strategy undertaken each
FY for the Clinical Operations division of the Office of Research
Administration
Provide regular reports including performance metrics and program
evaluation, such that various stakeholders have insight to program
progression
Exercise financial and contracts management oversight over all
sponsored and internally funded research accounts
Ensure coverage analyses, budgets and are developed and billing
plans are implemented for all clinical trials prior to trial
implementation
Work collaboratively with Research Finance to ensure accountability
for charges to the research accounts and the monitoring of
milestones, accounts receivable, and accounts payable
Serve on committees as appointed by the Executive Director
Manage the department budget as directed by Executive Director,
Director of Research Finance or designee
Provide the Executive Director, or designee, with fund projections
and staffing lists for both research and support staff on a regular
basis
Information Systems Management
Work collaboratively with the Development and Technology team to
bring forth a research submission process platform to assist in the
trial submission and tracking component of clinical trials
Work collaboratively with the Development and Technology team in
order to transition into CTMS environment
Develop a high degree of understanding of the CTMS functionality
and use cases
Oversee clinical research informatics touch points within the
clinical research operations teams as applicable.
Human Research Protections Management
Ensure post-approval monitoring of trials
Complete a high-level overview of audits, review audit findings and
discuss with clinical research staff
As necessary, design and implement process improvement plans in
collaboration with HRP leadership to facilitate clinical
operations
Business Development
In conjunction with Executive Director, identify and analyze
business opportunities to include partnerships with academia,
industry, technology companies, industry-funded, and
investigator-sponsored research awards, etc.
In conjunction with the Executive Director, develop and implement
and/or support a clinical trials pipeline function that will
effectively promote and engage MHS researchers, attract additional
funding into the MHS Research Program , provide access to care for
patients, and ultimately drive revenue from commercial sources
Identify and build a robust team of skilled investigators that
broaden the umbrella of therapeutic areas represented by MHS
Classify and manage allocation of professional resources for MHS
researchers to include protocol development, statistical modeling
and analysis, scientific writing, etc.
Assist researchers in developing process to analyze demographics,
quantify potential sample size based on key eligibility criteria
and/or identify potential research participants on approved MHS
research trials.
Provide direction and guidance to clinical research direct reports
and serve as a management resource for onboarding
Manage writing of -job -descriptions, hiring, layoffs,
terminations, evaluations, record keeping and other aspects of
personnel management
Provide direct supervision to the Manager(s) of clinical
operations, as well as support for all research staff, provide
staff training as necessary, prioritize and assign work to the
designated research staff and follow up to ensure accurate and
timely completion of work
Coordinate Manager-level work and responsibilities, as well as to
assist staff by answering questions and informing them of changes
in procedures
Hold regular meetings with department personnel to discuss
progress, process improvement, initiatives and issuing of
guidelines for internal procedures. Cascade information from the
Executive Director or designee or other leadership meetings
attended by the Director
Demonstrate ability to supervise and motivate all personnel within
reporting structure, including interviewing, selection, training,
performance reviews and disciplinary action
Provide exceptional customer service to the research community
Ensure adherence to Memorial Health Systems policies, procedures,
compliance and practices by all staff under this span of
control
The Director of Research Operations must possess deep content
expertise in clinical research operations as well as clinical
trials management and have a proven track record of excellent
leadership required for fostering effective collaboration between
MHS executive leadership and research operations leadership
Experience/Skills
Ten (10) years of current clinical research operations management
experience, preferred
5-8 years of healthcare management experience in a multi-specialty
research and/or inpatient healthcare provider environment,
preferred
5-8 years of clinical healthcare experience in a multi-specialty
healthcare setting, preferred
5 years of progressive responsible management experience with
strong leadership, planning and project management skills,
required
Knowledge of research design, research process, study budgets and
study implementation
Thorough understanding of research compliance requirements as well
as FDA, GCP and ICH Guidelines
Outstanding verbal and written communication skills with a keen
ability to engage the research community
Education/Licensure
Bachelor's degree required. Preferably in clinical healthcare field
(BSN, RPh) or healthcare administration, business, science or
related field.
Master's degree or higher preferred (PhD, MBA, Pharm.D., MSN)
"I love working at Miller Children's & Women's Hospital Long Beach
because I value working for a company that invests in its employees
and the community we serve. From the support and guidance I receive
from managers who value my professional and personal growth; to
being able to work alongside colleagues who are dedicated to help
their patients and families. I feel inspired every day to do the
work that I love alongside people who share a similar vision." Join
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