Reporting to the Manager, Regulatory Affairs, the Regulatory Affairs Coordinator (CRO) is responsible for preparing, submitting, and maintaining applications to the central ethics and clinical trial applications (CTA) to Health Canada. The Regulatory Affairs Coordinator (CRO) is also responsible of regulatory document preparation and writing informed consent forms.
The Regulatory Affairs Coordinator (CRO):
- Prepares, manages, and tracks central ethics and sites submissions; also responsible for submission to the Comité central d’éthique de la recherche (CCER).
- Acts as the primary point of contact for the central ethics committee.
- Prepares and submits Health Canada applications (e.g. CTA, CTA-A, CTA-N).
- Prepares study-specific templates of regulatory forms (e.g. QIU, CTSI, FDA1572, FDF).
- Writes informed consent forms.
- Manages translation requests with providers of translation services.
- May translate patient and advertisement materials.
- Reviews ethics and regulatory documents in the Investigator Site Files (before shipment to sites) and the Trial Master File.
- Ensures submission and renewal timelines are met.
- Informs central ethics and the investigators when new safety information is available.
- May participates in study specific tasks as delegated by management.
- May perform administrative tasks related to the general activities of the CRO-Operations group.
- May act as the backup for the Regulatory Affairs Coordinator (SITE).
- Bachelor in science;
- Specialized graduate diploma in drug development, regulatory affairs, is an asset ;
- Knowledge of clinical research, ICH /GCP Guidelines, and applicable regulatory requirements;
- 1 year experience in ethics and/or regulatory submission is an asset ;
- Bilingual French and English (excellent oral and written) ;
- Excellent knowledge of Word and Excel;
- Ability to organize own work, prioritize different assignments, and work under pressure;
- Attention to detail and accuracy in work;
- Versatile and comfortable in a multitasking environment;
- Quick learner.
- Respect established timelines, expectations, priorities, and objectives;
The work environment
At Innovaderm, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As an Accounts Receivable Technician, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
- Ongoing learning and development
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.
Job Types: Full-time, Permanent