Clinical Research Associate

**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.
- 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

Commitment to Diversity & Inclusion:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

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)

**Why Novartis?**

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Mumbai (Head Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.