Kelly Science, Engineering, Technology & Telecom · 18 hours ago
Senior Clinical Research Specialist
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $128K/yr
2+ years expKelly Science & Clinical is seeking a Senior Clinical Research Specialist for a contract position supporting clinical research activities. This role supports the Clinical R&D Department and involves executing company-sponsored clinical trials while fostering strong cross-functional relationships.
Staffing & Recruiting
Hiring Manager
Riley Pentheny
Responsibilities
Serve as a Senior Clinical Research Specialist within the Clinical R&D Department, supporting execution of company-sponsored clinical trials in compliance with timelines, milestones, regulations, and SOPs
Provide oversight and execution of clinical trial feasibility, site selection, study startup, conduct, and close-out within assigned countries
Act as a primary point of contact for clinical trial sites, including site management and ongoing communication
Contribute to the development of key clinical trial documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, study manuals, investigator brochures, annual reports, and publications
Ensure clinical trial registration and results posting on ClinicalTrials.gov from study initiation through completion
Manage and/or oversee investigational product ordering, tracking, accountability, and trial material logistics
Interface and collaborate with investigators, site staff, IRBs/ECs, vendors, contractors, and internal company partners
Oversee development and execution of investigator agreements and trial-related payments
Perform clinical data review activities in preparation for statistical analyses and scientific publications
Conduct monitoring activities as applicable, including site qualification, site initiation, interim monitoring, and close-out visits
Contribute to global Evidence Generation Strategies (EGS) and Evidence Dissemination Strategies (EDS), as assigned
Provide on-site protocol compliance and procedural support to investigational centers when required
Support critical literature assessment and interpretation of clinical evidence generated
Partner effectively with study core teams to deliver clinical project milestones on time, within budget, and in compliance with applicable regulations
Communicate business-related issues and opportunities to management and function as a trusted clinical project resource for stakeholders
Support study and project budget activities as assigned
Develop a strong understanding of the clinical pipeline, product portfolio, and business needs
Ensure personal and organizational compliance with all federal, state, local, and company regulations, policies, and procedures
Perform other duties as assigned
Operate with increasing independence for routine and moderately complex decisions, while escalating complex issues as appropriate
Qualification
Required
Bachelor's degree required, preferably in Life Science, Physical Science, Biological Science, or Nursing
Bachelor's degree with 2–4 years of relevant experience
Prior experience in clinical research or an equivalent clinical environment required
Strong working knowledge of clinical research processes, regulatory requirements, and global clinical trial standards
Proven ability to support and deliver clinical projects on time, within budget, and in compliance with regulations and SOPs
Excellent written, verbal, presentation, and technical writing skills
Strong organizational skills with the ability to manage multiple priorities
Ability to lead small study teams and support delivery of critical milestones
Demonstrates leadership in alignment with Johnson & Johnson Leadership Imperatives: Connect, Shape, Lead, Deliver
Ensure personal and organizational compliance with all federal, state, local, and company regulations, policies, and procedures
Preferred
Master's degree with at least 3 years of experience
PhD with at least 2 years of relevant experience
Medical device clinical research experience strongly preferred
Clinical or medical background a plus
Relevant professional certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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