メディカル・バイオ - 臨床開発モニター
メディカル・バイオ - 臨床開発QC・GCP監査
メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

・Study start-up作業への対応
・文書の英訳および和訳（自身による対応およびベンダー管理）
・治験国内管理人対応業務
・PMDA相談対応業務

Important duties and responsibilities associated with the job. ＞
• 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.

Responsibility ＞
The scope of the position, the type of impact, and the limits imposed by organization controls or by the work process.
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.

Contacts ＞
Principle recurring contacts, including their frequency and purpose.
• Frequent contact with Medpace project team members (internal), Sponsor contacts, and IRBs/ECs.

■休日：完全週休二日制, 年末年始

・MS Office (Excel, Word, OUTLOOK)中級レベル
・メールおよび口頭による英語でのコミュニケーション能力
・製薬会社、CRO業務、SMO業務経験者歓迎

Minimum Requirements
＞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.
• Bachelor’s degree;
• Proficient knowledge of Microsoft® Office software and Adobe® Acrobat;
• Demonstrate time management and professional oral and written communication skills; and
• Demonstrated ability to think critically, independently, and exercise good judgement.

＞Regulatory Submissions Coordinator I
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.
• 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 Medpace team members and investigative sites.

＞Regulatory Submissions Coordinator II
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.
• 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 Medpace and Sponsor Standard Operating Procedures; and
• Ability to interact with all Medpace team members and Sponsors on project-related issues.

＞Regulatory Submissions Coordinator III
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.
• 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.

＞Senior Regulatory Submissions Coordinator
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 independently
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 Medpace 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.

Mental Demands
The degree and type of independent judgment and mental effort needed to solve problems associated with the job.
The employee is expected to provide day-to-day support throughout trial. Initiative and insight are required to detect problems/discrepancies. Accuracy and consistency in work output are imperative.
Supervision Exercised
Number of employees directly and indirectly, type of work performed, type of supervision exercised, and identification of functional responsibility.
None.

■職種未経験者：不可