Senior Clinical Research Specialist

4 weeks ago


Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full time
Job Summary

We are seeking a highly skilled Senior Clinical Research Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our Clinical R&D Department, you will play a critical role in supporting the execution of company-sponsored clinical trials, ensuring compliance with timelines and study milestones.

Key Responsibilities
  • Oversee the execution of clinical trials, ensuring compliance with ICH-GCP, applicable legislation, and company Standard Operating Procedures.
  • Manage site relationships, including site initiation, monitoring, and close-out visits.
  • Develop and execute clinical trial documents, including study protocols, informed consents, CRFs, and monitoring plans.
  • Collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel to ensure successful trial execution.
  • Oversee the development and execution of investigator agreements and trial payments.
  • Responsible for clinical data review and preparation for statistical analyses and publications.
Requirements
  • Minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science.
  • Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
  • Previous experience in clinical research or equivalent required.
  • Medical device experience highly preferred.
What We Offer

As a Senior Clinical Research Specialist at Kelly Science, Engineering, Technology & Telecom, you will have the opportunity to work on complex clinical trials, develop your skills in clinical research, and contribute to the success of our company.

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

Apply now to join our team and take the next step in your clinical research career



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