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Clinical Research Associate
Novartis
posted 2hr ago
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Flexible timing
Key skills for the job
Job Description
Summary
This is a site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV Global Drug Development (GDD) trials within the country in adherence with monitoring procedures and processes in accordance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations and Standard Operating Procedures (SOPs). Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (From issue management to risk identification).
About the Role
This is a site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV Global Drug Development (GDD) trials within the country in adherence with monitoring procedures and processes in accordance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations and Standard Operating Procedures (SOPs). Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (From issue management to risk identification).
Key Responsibilities:
Your responsibilities include, but are not limited to:
Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and deliverables with true ownership attitude.
Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.
Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Key Responsibilities:
Your responsibilities include, but are not limited to:
Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and deliverables with true ownership attitude.
Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.
Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
:
Role Requirements :
Minimum Requirements:
Degree in scientific or healthcare discipline
2 years pharmaceutical industry experience or other relevant experience
Central/in-house monitoring or field monitoring experience
Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)
Degree in scientific or healthcare discipline
2 years pharmaceutical industry experience or other relevant experience
Central/in-house monitoring or field monitoring experience
Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)
Employment Type: Full Time, Permanent
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People are getting interviews through
(based on 102 Novartis interviews)
Job Portal
Referral
Company Website
Campus Placement
Recruitment Consultant
Walkin
32%
21%
14%
10%
3%
2%
18% candidates got the interview through other sources.
High
Confidence
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High Confidence means the data is based on a large number of responses received from the candidates.
What people at Novartis are saying
Rating based on 3 Clinical Research Associate
reviews
Anonymous · GDD
in Delhi
Likes
Great work culture. Managers treat you as equals. Your opinions and ideas are valued and acknowledged. Appraisals are in two figures. Overall a great company to be a part of.
Dislikes
As you move up the ladder after few promotions it becomes a little challenging to get promoted further as people who are above you do not leave thus leaving rare vacancies for the next role
Read 3 reviewsClinical Research Associate salary at Novartis
reported by
32
employees
with 1-5
years exp.
₹4
L/yr - ₹8.7
L/yr
43%
more
than the average Clinical Research Associate Salary in India
View more details
What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
View more benefits
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