Regulatory Affairs Assistant / Assistant(e) en Affaires Réglementaires

at  Innovaderm Research

The Regulatory Affairs Assistant is responsible for handling regulatory documents and maintaining the Investigator’s Study Files (ISFs) for all studies at the clinical research unit.

RESPONSABILITIES

More specifically, the Regulatory Affairs Assistant must:

• Track the signatures of regulatory forms (i.e., QIU, FDA1572, financial disclosure forms) and other required documents (i.e., protocol, Investigator’s Brochure) by necessary personnel;
• Prepare and update the various documents necessary for the creation of the files of the persons involved in a research project (e.g., delegation log, CV, attestation of training, etc.);
• Maintain the investigator’s study files (ISF) binders up to date;
• Assist the Clinical Research Coordinators and Assistant/Associate Clinical Research Coordinator in communicating with the CRA and performing clerical duties;
• Assist the Clinical Research Coordinators during regulatory inspections and sponsor audits;
• Assist with administrative work and other related tasks required for the Clinical Research Unit.

Requirements:

EDUCATION

• College degree;
• Diploma in Regulatory Affairs is an asset;

EXPERIENCE

• At least 1 year of experience in clinical research or regulatory affairs.

KNOWLEDGE AND SKILLS

• Bilingual French/English (excellent oral and written);
• Excellent knowledge of Word, Excel and PowerPoint;
• Quick learner, detail oriented, organized, good adaptability, and versatile.
  Our company:

Please refer the Job description for details