Sr. Clinical Research Specialist

Sr. Clinical Research Specialist - Medical Device

• Hybrid in Irvine, CA
• 20-30% Travel

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:
• 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
• 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 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
• 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

Qualifications:

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
• BS with at least 2-4 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.
• 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.