Clinical Research Specialist

Clinical Research Specialist

DUTIES & RESPONSIBILITIES

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position

• 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 milestone
• Participates 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 Procedure
• 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. www.clinicaltrials.gov) 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 perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study needs
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
• Assists in tracking assigned project budgets
• May perform other duties assigned as needed
• 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
• 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

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EXPERIENCE AND EDUCATION

Education:

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

Experience:

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred
• Previous experience in clinical research or equivalent is desired
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…)
• Clinical/medical background is a plus
• Medical device experience is a plus

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS: Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations
• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations
• Presentation and technical writing skills
• Written and oral English communication skills