Clinical Research Specialist

Clinical Research Specialist

Hybrid/Irvine, CA

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 division
• 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.
• 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.
• 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