Vita Global Sciences, a Kelly Company · 16 hours ago
Clinical Research Specialist
Irvine, CA
Contract
Hybrid
Entry, Mid Level
$45/hr - $45/hr
2+ years expVita Global Sciences, a Kelly Company, is seeking a Clinical Research Specialist to support clinical trials within their Clinical R&D Department. The role involves ensuring compliance with study milestones, coordinating trial activities, and fostering relationships with colleagues and clinical trial sites.
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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
Participates 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
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 perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
Assists in tracking assigned project budgets
May perform other duties assigned as needed
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 relevant experience
Previous experience in clinical research or equivalent is desired
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
Vita Global Sciences, a Kelly Company
From Research To Reality.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tim Southwick
President / Founder at Vita Global Sciences
Company data provided by crunchbase