FunctionClinical Trials / Research
¥3.2 - 7.5m
Our Client clinical is a contract research organization.
The employee will work closely with Regulatory Submissions Manager, Regulatory Manager, Project Coordinator, Graphic Design Specialist, and other Regulatory Submissions Coordinators. The employee will be responsible for performing tasks as listed above in order to meet goals, timelines, and demands of Clinical Operations.
- Distribute, track, review, and approve individual site Trial Master File (TMF) essential documentation at project start;
- Collect, review, organize, and assemble regulatory start-up submissions;
- Maintain timelines for regulatory submissions and site start-up;
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
- Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges;
- Utilize and assist in maintaining ClinTrak® (e.g., Essential Documents module);
- Work with Document Center to ensure necessary documentation is present; and
- Train and assist Clinical Research Associates on collection of essential documentation for on-going phase of project. Review documentation submitted by Clinical Research Associates and forward to client/Document Center
Regulatory Submissions Coordinator - Entry:
Duties are performed with close supervision and guidance from supervisor. The employee should begin to develop a basic understanding of clinical research and study start-up.
Regulatory Submissions Coordinator I:
- Bachelor’s degree;
- Proficient knowledge of Microsoft® Office software and Adobe® Acrobat;
- Demonstrate time management and professional oral and written communication skills;
- Demonstrated ability to think critically, independently, and exercise good judgement.
The employee is experienced enough to coordinate start-up and regulatory maintenance activities day-to-day with minimal orientation and oversight. A rapid increase in knowledge and understanding of study start-up and maintenance activities is expected.
Regulatory Submissions Coordinator II:
- Bachelor’s degree and at least 0.5 year of pharmaceutical research experience, or Master's degree within Life Sciences;
- Broad knowledge of clinical trial conduct, specifically, study start-up;
- Demonstrate fundamental knowledge of International Conference on Harmonization (ICH) guidelines and FDA or applicable local regulations; and
- Ability to interact effectively with team members and investigative sites.
The employee is experienced enough to function independently on a day-to-day basis with minimal orientation or oversight related to core responsibilities. Some oversight may be necessary for certain assignments.
Regulatory Submissions Coordinator III:
- Bachelor’s or Master's degree within Life Sciences and at least 1 year of Regulatory Submissions experience at Coordinator level or equivalent;
- Independent development and tracking of study start-up documents (status reporting, timelines, etc.);
- Demonstrate comprehensive knowledge of FDA or applicable local regulations, ICH guidelines, and company and Sponsor Standard Operating Procedures; and
- Ability to interact with all team members and Sponsors on project-related issues.
Highly proficient individual in Regulatory Submissions. Employee has enough experience that minimal project training is required. Expected to perform Regulatory Submissions Lead duties for moderately-sized projects as assigned. In addition, employee will provide insightful input on regulatory submissions documents (i.e., process, templates, TMF contents, etc.) and study start-up strategy.
Senior Regulatory Submissions Coordinator:
- Bachelor’s degree and at least 3 years of regulatory submissions experience, or Master's degree within Life Sciences and at least 2 years of regulatory submissions experience;
- Demonstrated ability to lead projects, performing all necessary duties in an accurate and timely manner; and
- Demonstrated ability to contribute to process/document improvements.
A senior level position. Highly proficient in all Regulatory Submissions activities. As necessary, this employee has the ability to successfully act as the Study Start-up Lead on assigned studies and is also able to efficiently manage departmental projects. Expected to communicate with external clients, vendors, and sites while keeping line and study management informed regarding project-related activities. In addition, employee is capable of performing Regulatory Submission Lead duties for large global projects as assigned.
- Bachelor’s degree and at least 5 years regulatory submissions experience, or Master's degree and at least 4 years of regulatory submissions experience;
- Advanced knowledge of Institutional Review Board (IRB) /Ethic's Committee (EC) processes, regulatory submissions, FDA or applicable local regulations, ICH guidelines, and study start-up processes;
- Demonstrated ability to provide leadership and guidance to other Regulatory Submissions Coordinators; and
- Demonstrated ability to support and augment department initiatives.