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Vita Global Sciences, a Kelly Company · 1 day ago

Senior Clinical Research Specialist

Irvine, CA

Contract

Onsite

Senior Level

Vita Global Sciences, a Kelly Company, is seeking a Senior Clinical Research Specialist to support clinical trials within the Clinical R&D Department. The role involves ensuring compliance with study timelines and regulations while fostering relationships across the organization.

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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, for the oversight/execution of 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

Serve as the primary contact for clinical trial sites (e.g. site management)

Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)

Ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed

Management/oversight of 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

May 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 appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects

If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center

Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated

Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)

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

Support project/study budget activities as assigned

Develop a strong understanding of the pipeline, product portfolio and business needs

Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures

Generally manages work with supervision, dependent on project complexity

Independent decision-making for simple and more advanced situations but required guidance for complex situations

Qualification

Clinical ResearchClinical Trial ManagementRegulatory ComplianceMedical Device ExperienceRelevant CertificationsTechnical WritingCommunication SkillsPresentation Skills

Required

Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required

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 setting, on time, within budget and in compliance to SOPs and regulations

Good presentation and technical writing skills

Good written and oral communication skills