Quality and Training Coordinator

This is a remote position with up to 50% travel.

Job Summary

The Quality and Training Coordinator will play a crucial role in the real-time review of study data and documentation at clinical sites to ensure accuracy, completeness, and compliance with GCP and protocol requirements. This role focuses on identifying errors, addressing deviations before they become systemic issues, and ensuring site documentation is always audit-ready. Additionally, the candidate will be responsible for identifying and working with the VP and QA Associate to develop training programs to enhance the skills and knowledge of our team members.

Education and Skills

• Minimum of 5 years of experience in the clinical research industry in a clinical Operations role (CRC, Site Manager, Regulatory Compliance or Research trainer). Bachelor's degree in Life Sciences, Healthcare, or related field (preferred, but not required). An equivalent combination of education, experience, and/or performance may be considered.
• Strong understanding of regulatory requirements related to clinical research (e.g., ICH GCP, FDA regulations).
• Experience in identifying and delivering training programs.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work collaboratively in a cross-functional team environment.
• Exceptional communication and presentation abilities
• Ability to adapt to evolving training needs and industry changes
• Experience working with electronic data capture systems and other clinical trial management tools.

Physical Demands

Requires extensive mobility: walking, standing, bending, stooping, kneeling, crouching, or crawling. Ability to sit for long periods of time. Pushing, pulling, and lifting of equipment. Requires mental alertness and accuracy for decision making. Requires ability to speak and hear. Repetitive motion required for extensive use of computers. Good visual acuity. Ability to lift up to 25 pounds. Ability to travel up to 50% of time

Mental Demands

• Requires English language skills for constant high-level written and interpersonal communications.
• Ability to work well with physicians, team members, Sponsors, and clients
• Must be able to multitask and to work independently with minimal supervision
• Ability to implement critical thinking skills
• Excellent professional, organizational, and communication skills
• Computer skills, word processing and data entry
• Multi-task and deadline oriented
• Strong interpersonal skills

Environmental Exposure

Possible exposure to blood borne pathogens. Possible exposure to chemical and electrical hazards.

NextStage Values and Culture

As a team member of NextStage, you are expected to demonstrate behaviors that reflect our Values and Culture and act in ways that promote the best interest of our patients, physicians, and customers entrusted to our care.

Position Responsibilities

• Conduct real-time data review of source documents, electronic case report forms (eCRFs), informed consent forms (ICFs), and regulatory files.
• Perform a review of patient data in a study to ensure early identification of errors and trends.
• Identify protocol deviations, data inconsistencies, and documentation gaps; escalate issues to the QA Associate.
• Work closely with Clinical Research Coordinators (CRCs) and Investigators at the sites to ensure proper documentation and timely data entry.
• Ensure Investigational Product (IP) accountability logs, subject visit checklists, and lab processing documentation are complete and accurate.
• Verify adherence to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
• Perform periodic QC checks on study binders and electronic regulatory systems to maintain inspection readiness.
• Collaborate with site staff to resolve data queries before monitoring or sponsoring reviews.
• Participate in site meetings to review quality metrics and corrective actions.
• Collaborate with cross-functional teams to investigate and analyze quality concerns and deviations.
• Work with VP and other stakeholders to implement strategies to ensure adherence to quality standards and regulatory requirements.
• Work with VP to design and develop comprehensive training programs to address identified gaps in knowledge and skills.
• Proactively identify areas for process improvement based on quality assessments and feedback.
• Foster a culture of continuous improvement by promoting best practices and knowledge sharing.
• Ensure that all quality-related activities and training efforts are well-documented and comply with regulatory requirements.