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- 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.
- 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.
- Minimum of a Bachelors/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.
- 2-4 years of relevant experience (or equivalent) required.
- Stroke Specific Device, Cardiac, and GI Device strongly preferred.
- 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
Clinical Research Specialist/Medical Device - Irvine, United States - Kelly Science, Engineering, Technology & Telecom
Description
Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This is a hybrid position. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
RESPONSIBILITIES
Business Leadership Responsibilities:
QUALIFICATIONS