Associate Clinical Research SpecialistKelly Science, Engineering, Technology & Telecom • Irvine, CA, US
Associate Clinical Research Specialist
Kelly Science, Engineering, Technology & Telecom • Irvine, CA, US
30+ days ago
Job type
- Full-time
Job descriptionServes as an Associate Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for under supervision Supports the clinical study team 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 Supports the clinical study team in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), and applicable trial registration on 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 May interface and collaborate with site personnel, IRBs / ECs, contractors / vendors, and company personnel Assists the clinical study team in overseeing the development and execution of Investigator agreements and trial payments Assists in clinical data review to prepare data for statistical analyses and publications If applicable, as part of a clinical trial, may assist in providing on-site procedural protocol compliance and data collection support to the clinical trial sites May also be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. Is responsible for communicating business related issues or opportunities to next managementlevel. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders. Minimum of a bachelor's degree preferably in Life Science, Physical Science, Nursing, or Biological Science required. BS, MS or PhD with at least 1 year of relevant experience preferred. Previous experience in clinical research or equivalent is desired. Clinical / medical background is a plus. Medical device experience is a plus.
Associate Clinical Research Specialist
- Experience managing device accountability, case scheduling, worked with Veeva / TMF
Associate Clinical Research Specialist will be responsible for supporting
one or several clinical trials and projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Education :
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Clinical Research Associate • Irvine, CA, US
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