Clinical Training Specialist II

2 weeks ago


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

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

Key Responsibilities
  • Complete all mandatory training as per DMCR requirements, including ICH-GCP Certification and IATA.
  • Ensure all relevant training is completed prior to the commencement of studies and maintained consistently thereafter.
  • Provide comprehensive training on:
    • Sponsor-provided and IRB-approved Protocol Training
    • All relevant Protocol Amendments Training
    • Essential Clinical Trial Documents and Investigator Site Binder maintenance.
    • Study-specific Manuals Training as applicable.
    • Sponsor-specified EDC and IVRS training.
  • Collaborate with HR and Organizational Development teams to deliver training to site personnel.
  • Conduct ongoing training based on performance evaluations and development plans.
  • Utilize QC, QA, and Central Services data trends to inform training initiatives.
  • Manage and coordinate Site DM training materials effectively.
  • Assist Site Management in leading internal training sessions.
  • Facilitate training to mitigate quality-related issues and promote a culture of quality.
  • Conduct study subject visits and ensure timely documentation of all relevant procedures.
  • Adhere to ALCOA-C Standards in all clinical trial documentation.
  • Implement laboratory manuals and protocol-specific procedures under the guidance of the Site/Study Management Team.
  • Engage with Laboratory, Data, Administrative staff, Clinical Investigators, and Sponsor/CRO representatives.
  • Maintain compliance with assigned protocols and stay updated on FDA regulations and ICH-GCP guidelines.
  • Oversee the reporting of Adverse and Serious Adverse Events as per internal guidelines.
  • Ensure timely data entry and query resolution in accordance with sponsor expectations.
  • Strive to meet subject enrollment goals for assigned protocols.
  • Participate in all required company meetings and submit necessary administrative paperwork on time.
  • Conduct patient consent discussions, ensuring clear communication of medical procedures, risks, benefits, and alternatives.
  • Facilitate effective communication among patients, healthcare providers, and research staff.
  • Comply with company travel policies and manage company credit card usage responsibly.
  • Perform any additional tasks as assigned by management.
Qualifications

Education:

  • BA/BS in health, life sciences, or a related field, or four years of experience in a clinical trials research setting may be considered.
  • 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 and/or presentations is preferred.

Credentials:

  • ACRP or equivalent certification is preferred.

Knowledge and Skills:

  • Extensive knowledge of electronic data capture systems and quick adaptability to new software.
  • Ability to exercise sound judgment and diplomacy in interactions with staff and study sites.
  • Capability to lead and educate cross-functional teams and site personnel.
  • Goal-oriented while consistently maintaining quality standards.
  • Proficient in verbal and written communication skills in English; bilingual (English/Spanish) skills are preferred.

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