Position: Senior Clinical Research Associate
Job Description:
Job Purpose: The role involves site relationship management to ensure sustainable trial execution at the site. The Senior Clinical Research Associate (sCRA) will perform on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, adhering to ICH/GCP, local regulations, and SOPs. The role includes proactive site performance management, early identification of site needs and issues, and acting as the single point of contact for all site-related activities.
Key Responsibilities:
- Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- Perform Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects.
- Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH/GCP, global and local regulations.
- Identify deficiencies in site processes, work closely with sites on risk mitigation and process improvements.
- Establish strong partnerships with sites to increase patient density and decrease issues.
- Perform Site Closeout activities, ensuring all follow-up activities and archiving requirements are met.
- Collaborate with SSO Clinical Project Manager (CPM), CRA Manager, MSL, CRMA, and medical advisor to ensure optimal recruitment, site development, and data quality.
- Participate in audit organization and inspection readiness activities for monitoring and site-related activities, ensuring implementation of corrective actions within specified timelines.
- Ensure the site Investigator Folder is up to date and collect essential documents from the site, keeping sTMF(s) updated.
Candidate Profile:
- Degree in scientific or healthcare discipline.
- Fluent in both written and spoken English and country language.
- Minimum 3 years of pharmaceutical industry experience or other relevant experience.
- Excellent time management and organizational capabilities, with the ability to prioritize and multi-task.
- Strong decision-making skills and a risk-based mindset.
- Good knowledge of the drug development process, specifically clinical trial/research.
- Clinical and therapeutic knowledge, understanding of international standards (GCP/ICH, FDA, EM), and the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance).
Additional Information:
- Qualification: Degree in scientific or healthcare discipline.
- Experience: Minimum 3 years.
- Job ID: REQ-10015289
- Location: Delhi (Office)
- Industry Type: Pharma / Healthcare / Clinical research
- Division: Development
- Business Unit: Innovative Medicines
- End Date: 30th August 2024
If you are interested in this opportunity, please apply by the end date.