Clinical Research Specialist

Vita Global Sciences, a Kelly Company; California (MO); Hybrid; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Paid time off

Job summary

Kelly Science and Clinical FSP in Irvine, CA is seeking a Clinical Research Specialist for a long-term engagement with a Global Medical Device client. This full-time role offers comprehensive benefits and opportunities within Kelly's FSP division.

You will execute company-sponsored clinical trials in the Medical Device division, liaise with the Clinical R&D teams, manage study activities and budgets, ensure GCP compliance, and support system/process improvements across sites.

Qualifications

• Bachelor’s/University Degree or equivalent required; life science, physical science, nursing or biological science preferred.
• 2-4 years of relevant experience.
• Previous experience in clinical trial management or equivalent is desired.
• Industry certifications preferred (e.g., CCRA, RAC, CDE).
• Clinical/medical background a plus; medical device experience.
• Understanding of Good Clinical Practices and applicable regulations.

Responsibilities

• Execute company sponsored clinical trials for the Medical Device division.
• Liaise with Clinical R&D Franchise and BSDM for projects.
• May serve as the primary contact for clinical trial sites.
• Manage operational activities of assigned studies.
• Track project budgets to ensure adherence to plans.
• Support implementation of new clinical systems/processes and publications.

Skills

Clinical trial management

Regulatory knowledge

Communication skills

Project coordination

Industry certifications

Education

Bachelor’s degree or equivalent

Job description

Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist for a long-term engagement in Irvine, California with one of our Global Medical Device clients. 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 will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

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

Posted By: Brendan Bartosiewicz