Clinical Research Associate

7 months ago

Toronto, Canada Novo Nordisk Full time

Clinical Research Associate

**Category**:Business Support & Administration**Location**:Toronto, Ontario, CA
- Toronto, Ontario, CA**Purpose of the Job**
- Drives the understanding & delivery of quality clinical research (patient safety, rights, and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for all monitoring and site management activities
- Takes ownership to deliver upon near-term North America Clinical Operations (NACO) goals, including successful delivery of studies within the clinical trial portfolio
- Contributes significantly to or leads complex or global cross-functional improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations
- Contributes significantly to a continually changing environment, supporting a future-focused approach, leveraging competencies, tools, and technology

**Key Areas of Responsibilities**:

- Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and strategies
- Implements and models proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials
- Verifies safety reporting and the proper handling, monitoring and storage of trial product according to trial specifications, NN SOPs, ICH-GCP guidelines, and relevant regulatory requirements
- Complies with relevant training requirements. Acts as local expert in assigned protocols. Proficient in therapeutic area knowledge sufficient to support role and responsibilities
- Ensures accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan, and other associated trial documents
- Drives recruitment and retention strategies to support clinical trial sites to meet country allocation enrollment and retention targets
- Identify potential risks and proactively take action to prevent or mitigate
- Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop and implement Corrective and Preventative Action Plans (CAPA)
- Shares information, collaborates and provides relevant input and guidance to other areas within NACO, CMR, and Global partners
- Demonstrates technical expertise within responsible areas, staying up to date on new practices, systems, and technologies, while building knowledge of emerging trends and advances within area
- Provides active coaching, mentorship and contributes to training of NACO staff to build insight and talent

**Other**:

- Adheres to the Novo Nordisk policies, procedures, vision, and fundamentals
- Acts as back up to other Clinical Research Associates, as requested
- Performs other tasks as assigned by management

**Key Compliance Accountabilities**:

- Drives the understanding & delivery of quality clinical research (patient safety, rights, and wellbeing; data reliability; scientific integrity; regulatory and process compliance)
- Complies with global SOPs by completing training in relevant systems by effective date to ensure local processes and responsibilities are current and in compliance with global SOPs.

**Goals**:

- Proactively manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACO and Novo Nordisk (e.g., clinical trial site staff, clinical research vendors)
- Proactively manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACO and Novo Nordisk (e.g., across NACO, CMR, International Operations (IO), and HQ R&D)
- Provides excellent customer service and builds strong working relationships with investigative sites and internal and external partners

**Education (Minimum Requirements)**:

- A Bachelor’s degree required* (Science-related discipline preferred)
- Alternatively, a Registered Nurse with a minimum of 4 years of on-site monitoring experience is acceptable, in lieu of a bachelor’s degree
- CRA/Monitoring training certificate an asset

**Experience (Minimum Requirements)**:

- A minimum of 6 years of clinical trial experience within pharmaceutical and/or healthcare setting of which at least 4 years has been in the role of an on-site monitoring CRA is required
- A minimum of 4 years of on-site monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research
- Requires understanding of medical and scientific concepts in or

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