Novartis is looking for an experienced Clinical Research Associate. In this role you will be the central point of communication between Novartis and Investigators, for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and Novartis SOP compliant.
Tasks and responsibilities
Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial.
Assume ambassadorial role to facilitate communication between sites and Key Novartis line functions to increase value proposition to investigators.
Facilitate preparation and collection of site level documents.
Execute site initiation and training activities.
Perform both on-site and remote monitoring visits according to monitoring plan.
Manage drug supply at site level.
Resolve site level update of technical systems
Ensure site activities are in-line with milestones (i.e. startup, recruitment, closeout, etc.)
Manage recruitment implementing appropriate contingency plans as needed.
Assure continual CP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training.
Author study monitoring reports.
Perform data query resolution process (both at Site and with Data Management).
Execute site closeout activities.
Act as a full responsible manager of assigned investigational sites.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Degree in a scientific or health care discipline is preferred
Fluent English (oral and written).
What you bring to the role
Basic medical and business knowledge.
Desired experience: 2 years or more in clinical research
Understands and can apply knowledge of clinical trial designs to trial execution.
Knowledge and experience in international Standards (GCP/ICH), international (FDA, EMA) and local regulations.
Expertise in communication, managing multiple priorities and computer literacy.
What we offer as an employer:
A curious, unbossed and inspiring international work environment;
Being a part of the dynamic, diverse and flexible team, responsible for many of tomorrow’s innovations;
Plenty of chances to work on your personal development;
Excellent working conditions.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Do you have any questions about this vacancy? Please feel free to contact the Novartis Recruitment team at firstname.lastname@example.org.