Overview
Senior Clinical Research Associate Jobs in Calgary – Alberta at Novo Nordisk A/S
Title: Senior Clinical Research Associate
Company: Novo Nordisk A/S
Location: Calgary – Alberta
Category: Science, Pharmaceutical
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 …
