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.
• As applicable, assigns metadata in the eTMF or maintains trackers for the paper TMF.
• Sets up the conduct of eTMF quality reviews and addresses quality review findings.
• Works with the study team to resolve issues identified during electronic document uploads into the eTMF.
• Receives and reviews regulatory documents from investigative sites for accuracy and compliance with company SOPs and regulations.
• Assembles and ships the Investigator’s Study File (ISF) to investigative sites.
• May serve as in-house contact to support Clinical Research Associates (CRAs).
• Runs monthly reports to ensure accuracy of files.
• Resolves internal quality control findings or external compliance audit findings.
• Delivers the Trial Master File at study closeout.
• Participates in various administrative tasks as required to accomplish the goals of the projects and the needs of the project teams.

REQUIREMENTS

Education

• College degree

Experience

• Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry
• Experience in the development and maintenance of the TMF is considered a strong asset

Knowledge and skills

• Basic knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements
• Bilingual French and English (intermediate)
• Computer skills including proficiency in the use of Microsoft Word and Excel
• Ability to 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 Innovaderm, 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 
• Full-time position 
• Ongoing learning and development 

About Innovaderm  

Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe. 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals.

Innovaderm only accepts applicants who can legally work in India.