Clinical Research Specialist

Serves as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device division Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under him/her responsibility May serve as the primary contact for clinical trial sites Manage operational activities of assigned clinical studies within the Clinical R&D Operations group Solves problems with support from Clinical Management arising during clinical trial execution Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed Track assigned projects budgets to ensure adherence to business plans Support the implementation of new clinical systems/processes, and provide support for publications, as needed. Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance Ensure efficient use of resources within the clinical study/program to provide high quality deliverables. Business Leadership Responsibilities: Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials. May lead several non-regulated small clinical trials and/or a small number of non-regulated medium trials that may involve other clinical operations staff. May assist with the management of large regulated or complex trials under supervision of CTM or Senior CTM. Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities. Qualifications: Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science. 2-4 years of relevant experience (or equivalent) required. Previous experience in clinical trial management or equivalent is desired. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE). Clinical/medical background a plus. Requires understanding of Good Clinical Practices Understanding and application of regulations and standards applied in clinical areas/regions is required Presentation skills and influencing of others Written and oral communication skills Demonstrated competencies in the following areas are required: Behaving in a professional and ethical manner #J-18808-Ljbffr