Regulatory Research Coordinator

Classification & Regular Hours

Hours per Week: 35

Salary Grade: 13

Please note, this is a wholly granted funded, 1 year temporary full time contract opportunity.

Secondments are Welcome

Click here for more details on secondment opportunities.

About Western

With an international reputation for success, Western ranks as one of Canada's top research-intensive universities. Our research excellence expands knowledge and drives discovery with real-world application. Western also provides an exceptional employment experience, offering competitive salaries, a wide range of employment opportunities and one of Canada's most beautiful campuses.

About Us

The Robarts Research Institute within the Schulich School of Medicine & Dentistry at Western University has made its mission to accelerate medical discovery. Through a powerful integration of basic and clinical research, we are driving major advances that impact on many of today's most devastating diseases.

The mission of the APILab is to transform outcomes in patients with asthma and COPD by accelerating patient-facing imaging physics discoveries, research and development and implementing/validating these findings in clinical and translational studies.

Responsibilities

The Regulatory Research Coordinator will be responsible for supporting the operationalization of research studies under the direction of a Principal Investigator. The role will be responsible for the preparation, review, and management of submissions to local and national regulatory bodies for the purpose of research studies according to Good Clinical Practice (GCP) and International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines. The Coordinator will lead the creation of responses required for the processing and approval of applications including Investigational Testing Authorizations, Clinical Trial Applications and local ethics submissions, including those required at hospital coordinating sites. The role will be a point of contact for internal and external inquiries related to the studies, coordinate and oversee the logistical and day-to-day activities, and will provide training for all staff members, collaborators and graduate students to plan, coordinate, and execute participant visits for research studies according to GCP guidelines. The role will design database structures using specialized software, determine the impact of new protocols and protocol amendments on database design, and will implement changes based on forecasted errors that may occur. The Coordinator will be knowledgeable in all aspects of the studies and will design and conduct regular data and GCP audits to resolve any discrepancies within the data.

Qualifications

Education:

• Bachelor of Science (BSc) degree, Registered Respiratory Therapist (RRT), Registered (RN or BScN) or Practical Nurse (RPN) or equivalent education and experience

Experience:

• 2 years of experience supporting research studies in a research or clinical environment
• Previous clinical and clinical research experience
• 2 years regulatory experience including Health Canada and local ethics submissions would be an asset

Knowledge, Skills & Abilities:

• Familiarity with techniques for planning, managing and coordinating multiple projects, with competing priorities that involve a variety of stakeholders
• Knowledge of development and implementation of databases for research studies using REDCap
• Experience with electronic Common Technical Document (eCTD) format submissions, especially Class 2 medical device applications
• In depth knowledge of relational databases including database and form development, troubleshooting, and report design
• Understanding of research done in the field in order to make decisions for data management and database design
• Demonstrated ability to make decisions based on competing high priority tasks
• Ability to manage clinical data ensuring quality, accuracy, and consistency with clinical charts while maintaining confidentiality
• Ability to multi-task in a fast paced, clinical research environment
• Ability to write clear, concise procedural and technical documentation for submission to regulatory bodies
• Ability to liaise between multiple departments in order to conduct daily research activities
• In depth knowledge of Good Clinical Practice and current ethical standards
• Ability to work in a collaborative research environment, and build and maintain lasting relationships with other departments, key partners, and external agencies
• Communication skills with the ability to converse with, write reports for, and deliver presentations to all levels of the organization
• Ability to write clear, concise and accurate procedural documentation
• Ability to ensure confidentiality and privacy is maintained through the appropriate retention and destruction of information
• Attention to detail and proofreading abilities with an excellent command of the English language
• Ability to display a blend of diplomacy and persistency to achieve goals while working collaboratively
• Ability to work within a flexible schedule to accommodate the research group’s events and activities
• Project management skills to manage multiple projects simultaneously from conception to completion within tightly prescribed timelines
• Proven ability and natural inclination to develop relationships by interacting with people in a professional, respectful and diplomatic manner
• Familiarity with University research policies and practices

Western Values Diversity

The University invites applications from all qualified individuals. Western is committed to employment equity and diversity in the workplace and welcomes applications from women, members of racialized groups/visible minorities, Indigenous persons, persons with disabilities, persons of any sexual orientation, and persons of any gender identity or gender expression. Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please contact Human Resources or phone 519-661-2194.

Please Note:

We thank all applicants for their interest; however, only those chosen for an interview will be contacted.