Regulatory Operations Coordinator, Based in
7 days ago
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
**Job Overview**
The Regulatory Ops Coordinator supports the conduct of study execution and completion of required documentation. Responsible for ensuring the study documentation is accurate, complete, and well organized in accordance with internal and regulatory standards.
**Essential Functions**:
- Supports internal and external stakeholders to ensure study set up and site initiation as detailed in the protocol documentation.
- Supports with internal and external stakeholders to ensure qualification visits are scheduled.
- Compiles documentation from lab analysis in study binder.
- Ensures study documentation is complete and accurate.
- Supports the scheduling and hosting of monitoring visits with sponsors.
- Responsible for follow up on sponsor visit findings to ensure appropriate resolution.
- Files deviation documentation, as needed. May participate in investigation and resolution.
- Ensures effective communication between the sponsor and lab operations related to study.
- Attends study calls to stay abreast of study needs and ensures follow up on assigned actions.
- Ensures adequate inventory of reagents for training and sample analysis.
- Coordinates training for lab staff to ensure competency and regulatory requirements are met.
- Partners with management to ensure training records for lab staff dedicated to the study are up to date.
- Partners with lab management to ensure sample analysis in accordance with study timelines.
- Ensures effective coordination of multiple studies to ensure regulatory compliance and sponsor expectations are met.
- Identifies opportunities for process improvement and suggests best practices for effectivness.
- Responsible for supporting six sigma, quality, and safety initiatives.
**Qualifications**:
- Bachelor's Degree Req Or
- Other equivalent combination of education and experience
- 6 months experience in a regulated laboratory environment.
- Sound knowledge of good documentation practices.
- Working knowledge of laboratory workflows.
- Proficiency in standard computer operating systems and navigating file based transfer systems.
- Strong interpersonal, communication, organizational, and time management skills.
- Demonstrated ability of critical thinking and problem solving.
- Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
- Demonstrated ability to handle multiple competing priorities.
- utilize resources effectively.
- Strong attention to detail and accuracy.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Applicable certifications and licenses as required by local regulations.
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