Clinical Research Specialist

Responsibilities

• 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 his/her responsibility.
• Serves as the primary contact for clinical trial sites.
• Manages 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.
• Provides 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.
• Might be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed.
• Tracks assigned projects budgets to ensure adherence to business plans.
• Supports the implementation of new clinical systems/processes, and provides support for publications, as needed.
• Interfaces and collaborates with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.
• Ensures personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
• Ensures efficient use of resources within the clinical study/program to provide high quality deliverables.

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.
• Medical device experience.
• 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, Technical writing skills.