Senior Clinical Research Specialist

About the role

Kelly Science and Clinical FSP is seeking a Senior Clinical Research Specialist for a long-term, full-time engagement in Irvine, CA with a Global Medical Device client. This role is part of the Kelly FSP (Functional Service Provider) division, offering full benefit options including Medical, Dental, Vision, 401K, and paid time off (holiday, vacation, sick/personal).

The Senior Clinical Research Specialist will support one or several clinical trials within the Clinical R&D Department, fostering strong relationships with colleagues across the organization.

Responsibilities

• Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company-sponsored clinical trials, ensuring compliance with timelines and study milestones.
• Oversee/execute feasibility, selection, set-up, conduct, and closure of clinical trials within allocated countries, in accordance with ICH-GCP, applicable legislation, and Company Standard Operating Procedures.
• May serve as the primary contact for clinical trial sites (e.g., site management).
• Contribute to the development of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) and ensure registration on www.clinicaltrials.gov from study initiation through posting of results; support publications as needed.
• Manage/oversee ordering, tracking, and accountability of investigational products and trial materials.
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Oversee the development and execution of Investigator agreements and trial payments.
• Responsible for clinical data review to prepare data for statistical analyses and publications.
• If applicable, perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits, or close-out visits based on study need.
• May contribute to the development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within assigned projects.
• If applicable, provide on-site procedural protocol compliance and data collection support to the center as part of a clinical trial.
• Contribute to the critical assessment of literature and interpretation/dissemination of all evidence generated.
• Deliver assigned clinical projects through effective partnership with the study core team, ensuring on-time, within-budget, and compliant delivery.
• Communicate business-related issues or opportunities to the next management level and function as a trusted resource of accurate, up-to-date project knowledge for key stakeholders.
• Support project/study budget activities as assigned.
• Develop a strong understanding of the pipeline, product portfolio, and business needs.
• Ensure personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Requirements

• Minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science.
• Experience: BS with at least 2-4 years, MS with at least 3 years, or PhD with at least 2 years of relevant experience preferred.
• Previous experience in clinical research or equivalent is required.
• Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
• Clinical/medical background is a plus.
• Medical device experience highly preferred.

Skills

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations.
• Proven track record in supporting delivery of clinical projects within clinical/surgical research settings, on time, within budget, and in compliance with SOPs and regulations.
• Strong presentation and technical writing skills.
• Excellent written and oral communication skills.
• Leadership abilities, including:
  • Ability to lead small study teams to deliver critical milestones.
  • Develop collaborative relationships with key internal and external stakeholders.
  • Make recommendations for and actively participate in departmental process improvement activities.
  • Take ownership in critical scientific thinking and development of self.
  • Engage in transparent and constructive conversations.
  • Strive to ensure all deliverables on allocated studies are met on time and within budget.

Benefits

• Medical, Dental, and Vision coverage.
• 401K retirement plan.
• Paid time off, including holiday, vacation, and sick/personal time.