Our J&J MedTech Neurovascular clinical team is currently seeking a Senior Clinical Research Specialist. The role is based in Irvine, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
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This Senior Clinical Research Specialist will be responsible for supporting multiple clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
POSITION RESPONSIBILITIES:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
· 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 JnJ MedTech Neurovascular
· Generally, manages work with some supervision, dependent on project complexity. Independent decision-making for simple and some more advanced situations, but requires guidance for complex situations
· 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
· Ability to serve as the primary contact for multiple clinical trial sites (e.g., site management)
· Ability to serve as the primary contact and liaison for clinical trial vendor(s), driving and tracking achievement of vendor-related study milestones
· Contribute towards development and drafting of clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual report)
· 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
· Develop strong collaborative relationships 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
· If applicable, 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
· Demonstrate 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
· Perform other duties assigned as needed