Kelly Science, Engineering, Technology & Telecom · 16 hours ago
Clinical Research Specialist
Irvine, CA
Full-time
Hybrid
Entry, Mid Level
$85K/yr - $95K/yr
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a Clinical Research Specialist to support clinical trials within the Clinical R&D Department. The role involves ensuring compliance with study timelines, assisting in trial document development, and coordinating with various stakeholders to facilitate successful clinical research activities.
Staffing & Recruiting
Hiring Manager
Kellie Pharr
Responsibilities
Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
Participate in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
Study start up activities, from helping with feasibility, all the way to site activations, could be possibility of maintenance IRB to support the studies
May serve as the primary contact for clinical trial sites (e.g. site management)
Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Interfaces and collaborates with Clinical Research Associates (CRAs)
Assists in overseeing and supports the development and execution of Investigator agreements and trial payments
Assists in clinical data review to prepare data for statistical analyses and publications
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
Assists in tracking assigned project budgets
Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Should develop a strong understanding of the pipeline, product portfolio and business needs
Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations
Qualification
Required
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
BS with at least 2 years of experience in clinical research
CTMS experience, familiarity with TMF, solid understanding, quality of the documents, GCP, GDP
Preferred
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Clinical/medical background is a plus
Medical device experience is a plus
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
Company data provided by crunchbase