Jobs via Dice ยท 1 day ago
Senior Clinical Research Specialist
Irvine, CA
Full-time
Onsite
Mid, Senior Level
3+ years expDice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking a Senior Clinical Research Specialist to support clinical trials within the Clinical R&D Department, ensuring compliance with study timelines and fostering relationships across the organization.
Computer Software
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-Google Cloud Platform, applicable legislation and Company Standard Operating Procedures
May 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 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
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
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
Perform other duties assigned as needed
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
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred
Previous experience in clinical research or equivalent is 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
Ability to lead small study teams to deliver critical milestones, as may be assigned
Develop collaborative relationships with key internal and external stakeholders
Make recommendations for and actively participate in departmental process improvement activities
Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations
Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations
Preferred
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV,...)
Clinical/medical background a plus
Medical device experience highly preferred
Benefits
Medical
Dental
Vision
401K (no match)
Paid time off
Holiday
Vacation
Sick/personal time
Company
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Funding
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Early StageCompany data provided by crunchbase