Clinical Operations Director
Company: Research & Development Institute, Inc
Location: Los Angeles
Posted on: September 18, 2024
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Job Description:
Research & Development Institute (RDI) is a tech-enabled CRO
that helps In Vitro Diagnostic manufacturers who struggle to get
FDA clearance for their products by sourcing the blood samples they
desperately need through physicians and labs.RDI received a large
investment in 2021 that has allowed it to transition from a founder
led business into a world-class diagnostic CRO with scientific
experts and a CLIA lab that allow it to manage larger and more
profitable projects.Job OverviewManage a team of clinical staff
working in support of clinical studies to ensure projects are
appropriately resourced and employees are trained and meeting
project objectives.Essential Functions--- Manage staff in
accordance with policies and applicable regulations.
Responsibilities include planning, assigning, and directing work,
assessing performance and guiding professional development,
rewarding and disciplining employees, and addressing employee
relations issues and resolving problems.--- Participate in the
selection for hiring new employees by conducting candidate review
and participating in the interviewing process. Ensure that new
employees are properly onboarded and trained.--- Ensure that staff
has the proper materials, systems access and training to complete
job responsibilities. Provide oversight for the execution of the
training plan, SOP review and training experiences, as
applicable.--- Participate in the allocation of resources to
clinical research projects by assigning staff to clinical studies
based on their experience and training.--- Manage the quality of
assigned staff's clinical work through regular review and
evaluation of work product.--- Identifies quality risks and issues
and create appropriate corrective action plans to prevent or
correct deficiencies in performance of staff.--- Ensures that staff
are meeting defined workload and quality metrics through regular
review and reporting of findings as outlined by clinical operations
management.--- May collaborate with other clinical teams and other
functional leadership to manage project related challenges and to
achieve exemplary customer service.--- Participates in corporate or
organizational departmental quality or process improvement
initiatives.Qualifications--- Prior clinical trial experience
including experience in a management/leadership capacity or
equivalent combination of education, training and experience.---
In-depth knowledge of applicable clinical research regulatory
requirements (i.e., Good Clinical Practice (GCP) and International
Conference on Harmonization (ICH) guidelines).--- Good leadership
skills.--- Computer skills including proficiency in use of
Microsoft Word, Excel and PowerPoint.--- Written and verbal
communication skills including good command of English.---
Excellent organizational and problem solving skills.--- Effective
time management skills and ability to manage competing
priorities.--- Ability to establish and maintain effective working
relationships with coworkers, managers, and clients.
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Keywords: Research & Development Institute, Inc, Hemet , Clinical Operations Director, Executive , Los Angeles, California
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