Job Description

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Senior Clinical Research Associate

Category: Clinical Development

Location:

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 order to effectively interpret protocol requirements, support sites and effectively conduct monitoring activities. The CRA role is complex and requires the ability to balance multiple competing priorities, stakeholders, timelines and mitigating risks
• Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
• Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills

Working Conditions:

• Works independently
• May be required to travel to location to perform duties of the job
• 50-75% business travel required
• May be required to work company holidays and weekends

Other:

• Bilingual (French and English) is an asset
• Ability to work within a team (international and local)
• Ability to prioritize tasks to meet workload requirements
• Excellent communication skills (verbal, written, presentation) in English
• Strong attention to detail
• Demonstrates collaborative and stakeholder management skills, while engaging in organizational initiatives and implementing RBQM principles

Application Deadline: December 18th 2023

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

Novo Nordisk