Vita Global Sciences, a Kelly Company ยท 1 day ago
Senior Clinical Research Specialist (Amanda)
Irvine, CA
Contract
Onsite
Senior LevelVita Global Sciences, a Kelly Company, is seeking a Senior Clinical Research Specialist for a long-term engagement in Irvine, CA. This role involves supporting clinical trials within the Clinical R&D Department and fostering relationships with colleagues 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
Required
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
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
Work with a sense of urgency
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
Preferred
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Clinical/medical background a plus
Medical device experience highly preferred
Benefits
Medical
Dental
Vision
401K
Paid time off, including holiday, vacation, and sick/personal time
Company
Vita Global Sciences, a Kelly Company
From Research To Reality.
Founded in 2014
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tim Southwick
President / Founder at Vita Global Sciences
Company data provided by crunchbase