Clinical Research Specialist

This Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Participate in the 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
• Study start up activities, from helping with feasibility, all the way to site activations, could be possibility of maintenance IRB to support the studies
• May serve as the primary contact for clinical trial sites (e.g. site management)
• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
• Supports applicable trial registration (e.g.(Use the "Apply for this Job" box below).) from study initiation through posting of results and support publications as needed
• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
• Interfaces and collaborates with Clinical Research Associates (CRAs)
• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments
• Assists in clinical data review to prepare data for statistical analyses and publications
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
• Assists in tracking assigned project budgets
• Is 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
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Should develop a strong understanding of the pipeline, product portfolio and business needs
• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations

Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

• BS with at least 2 years of experience in clinical research
• CTMS experience, familiarity with TMF, solid understanding, quality of the documents, GCP, GDP
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)