Regulatory Documents Assistant


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

 

The Regulatory Documents Assistant:

 

  • Collaborates with the Project Assistant to develop the list of expected documents in the TMF.
  • 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 assist project Managers and assistants with the creation and maintenance of tracking 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 the projects and the needs of the project teams.

 

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

 

PROFILE

 

  •  College degree;
  • Basic knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements;
  • Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry;
  • 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.

 

About Innovaderm

 


Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 1999, 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.

 


We thank you for your application and please note that only those selected for an interview will be contacted.


Innovaderm only accepts applicants with a work permit for Canada.

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