Clinical Training Specialist II

2 weeks ago


Houston, Texas, United States DM Clinical Research Full time
Job Overview

The Clinical Training Coordinator II (Travel) is responsible for ensuring that high-quality research is conducted at designated investigative sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. This role is pivotal in delivering superior quality data to sponsors and enhancing the performance and skills of site staff through effective training programs.

Key Responsibilities
  • Complete all required training, including ICH-GCP Certification and IATA, in a timely manner.
  • Ensure all relevant training is completed prior to the commencement of studies and maintained continuously.
  • Provide training on sponsor-provided and IRB-approved protocols, including amendments and essential clinical trial documents.
  • Collaborate with HR and Organizational Development teams to deliver comprehensive training to site personnel.
  • Conduct ongoing training initiatives based on performance evaluations and quality trends.
  • Manage and coordinate site-specific training materials and assist in leading internal training sessions.
  • Conduct patient consent discussions, ensuring comprehension of medical procedures and study protocols.
  • Maintain compliance with ALCOA-C standards and oversee the reporting of adverse events.
  • Strive to meet enrollment goals set by sponsors for assigned protocols.
  • Prepare and submit necessary administrative documentation as per company timelines.
Qualifications

Education:

  • BA/BS in health, life sciences, or a related field, or equivalent experience in a clinical trials research setting.
  • Foreign Medical Doctor Degree is preferred.

Experience:

  • A minimum of 2 years of experience as a Clinical Research Coordinator, preferably in coordinating industry-sponsored vaccine trials.
  • At least two years of experience in clinical trials research training or presentations is preferred.

Certifications:

  • ACRP or equivalent certification is preferred.

Skills:

  • Proficient in electronic data capture systems with a quick learning ability for new software.
  • Strong judgment and diplomacy skills when interacting with staff and study sites.
  • Ability to lead and educate cross-functional teams and site personnel.
  • Excellent verbal and written communication skills in English; bilingual (English/Spanish) skills are preferred.

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