Senior Clinical Research Associate (CRA) – Clinical Trials Monitoring
Job Summary:
We are hiring an experienced Senior Clinical Research Associate (CRA) to join our clinical operations team. This role is perfect for candidates with a minimum of 3 years of site monitoring experience, strong knowledge of GCP principles, and hands-on expertise in trial setup, site initiation, and study conduct activities. The position offers involvement across various phases of clinical trials and direct interaction with investigators, clients, and internal project teams.
Key Responsibilities:
Ensure adherence to ICH E6 principles and applicable SOPs during all clinical activities.
Conduct feasibility assessments, site selection, and trial setup activities.
Negotiate and facilitate Investigator/site contract execution.
Develop and adapt study-specific documentation locally.
Manage and maintain the Trial Master File (TMF).
Facilitate regulatory submissions and participate in Investigator’s meetings.
Perform site initiation, site monitoring, and site closeout visits.
Maintain regular communication with study teams, clients, and vendors, acting as a backup to the Project Manager/Project Team Lead when required.
Resolve site-level issues and escalate them to PM as necessary.
Support Project Managers with project updates and documentation.
Participate in client meetings, teleconferences, and cross-functional discussions.
Oversee CRF retrieval and query resolution processes.
Conduct project closeout activities efficiently and as per SOPs.
Required Skills & Qualifications:
Minimum 3 years of independent clinical monitoring experience.
Strong understanding of Good Clinical Practice (GCP) principles and local regulatory requirements.
Familiarity with Trial Master File (TMF) management.
Experience in site selection, initiation, monitoring, and closeout.
Excellent communication and problem-solving skills.
Ability to work independently and manage multiple trial sites.
Proficiency in using MS Office tools and clinical trial management systems.
Perks & Benefits:
Involvement in global clinical trials and exposure to international clients.
Career growth opportunities in clinical operations.
Professional training and development programs.
Competitive compensation package (not disclosed in JD).
Collaborative and supportive work environment.
Company Description:
A renowned clinical research organization dedicated to advancing pharmaceutical and healthcare innovations. The company provides end-to-end services in clinical trial management, regulatory affairs, and drug development for global pharmaceutical and biotechnology clients.
Work Mode:
On-site / Hybrid (Location not specified in JD)
Call to Action:
Ready to drive impactful clinical trials? Apply now to become a Senior Clinical Research Associate and play a key role in cutting-edge clinical research projects.
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