Join Kelly FSP as a Clinical Research Specialist with our Medical Device client in Irvine, CA
This is a hybrid position Tuesday/Thursday and every other Friday on site.
RESPONSIBILITIES
Serves as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
May serve as the primary contact for clinical trial sites
Manage operational activities of assigned clinical studies within the Clinical R&D Operations group
Solves problems with support from Clinical Management arising during clinical trial execution
Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
Track assigned projects budgets to ensure adherence to business plans
Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.
Business Leadership Responsibilities:
Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.
May lead several non-regulated small clinical trials and/or a small number of non-regulated medium trials that may involve other clinical operations staff (i.e., <150K USD annual investment).
May assist with the management of large regulated or complex trials under supervision of CTM or Senior CTM.
Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.
QUALIFICATIONS
Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
2-4 years of relevant experience (or equivalent) required.
Previous experience in clinical trial management or equivalent is desired.
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Clinical/medical background a plus.
Medical device experience a plus.
Requires understanding of Good Clinical Practices
Understanding and application of regulations and standards applied in clinical areas/regions is required
Presentation skills and influencing of others
Written and oral communication skills
Demonstrated competencies in the following areas are required:
Behaving in a professional and ethical manner
Technical writing skills
