Regulatory Documents Assistant
2 days ago
The Regulatory Documents Assistant will establish and maintain the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial and will perform record review of essential documents for accuracy and quality according to ICH-GCP. The Regulatory Documents Assistant is also responsible for the set-up of the Investigator’s Study File (ISF) binders.**__**
****RESPONSABILITIES**
- Participates in the development of the TMF structure.
- Participates in the development of the electronic TMF (eTMF) Management Plan.
- Files or imports documents in the TMF.
- Performs record review of essential documents for accuracy and quality in the TMF.
- Assigns metadata and maintains trackers for the TMF.
- Sets up the conduct of eTMF quality reviews, performs, and addresses quality reviewfindings.
- Collaborates with the Project Assistant to define project scope and to develop the list ofexpected documents in the TMF.
- Works with the study team to resolve issues with the TMF.
- Receives and reviews regulatory documents from investigative sites for accuracy andcompliance with company SOPs and regulations.
- May assist project managers and coordinators with the creation and maintenance oftracking tools and study material.
- May assist with preparing shipments of study supplies to clinical sites.
- May serve as in-house contact to support Clinical Research Associates (CRAs).
- Participates in various administrative tasks as required to accomplish the goals of theprojects and the needs of the project teams
**Requirements**:
- College degree;
- Knowledge of clinical trial operations;
- Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry;
- English (intermediate); French (Asset).
- Computer skills including proficiency in the use of Microsoft Word and Excel;
- Ability to organize own work and prioritize different assignments;
- Attention to detail and accuracy in work;
- Respect established timelines, expectations, priorities, and objectives;
- Versatile and comfortable in a multitasking environment
Our company:
**The work environment**
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
**About Indero**
Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
**_ Indero only accepts applicants who can legally work in India._**
Brand name:
Indero
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