Senior Clinical Research Associate – Clinical Trials Management (3+ Yrs Exp)
Job Summary:
We are hiring an experienced Senior Clinical Research Associate (CRA) to strengthen our clinical research operations team. This role requires expertise in feasibility assessment, trial setup, site monitoring, and regulatory submissions in compliance with ICH E6 principles and GCP guidelines. Ideal for candidates with a minimum of 3 years of clinical monitoring experience, this position offers exposure to global clinical trials and cross-functional project management.
Key Responsibilities:
Ensure all trial activities comply with ICH E6 GCP principles and internal SOPs.
Conduct feasibility assessments, site selection, and project setup activities.
Negotiate and facilitate Investigator/site contract execution.
Develop and adapt study-specific documentation as per local requirements.
Setup and maintain the Trial Master File (TMF) throughout the project lifecycle.
Facilitate regulatory submissions and manage communications with stakeholders.
Organize and participate in Investigator’s meetings, site initiation, and monitoring visits.
Act as backup for Project Manager/Project Team Lead in client and vendor communications.
Resolve site-level issues and escalate to the Project Manager when necessary.
Support CRF retrieval, query management, and project closeout activities.
Conduct site closeout visits ensuring proper documentation and compliance.
Required Skills & Qualifications:
Minimum 3 years of independent clinical monitoring experience.
Strong knowledge of GCP principles and local regulatory requirements.
Familiarity with Trial Master File (TMF) management practices.
Proficiency in feasibility, site initiation, monitoring, and closeout processes.
Effective communication and problem-solving skills.
Ability to manage multiple trial sites with minimal supervision.
Proficient in using MS Office and clinical trial management systems (CTMS).
Perks & Benefits:
Work on global clinical research projects with top pharma clients.
Career growth opportunities in clinical operations and trial management.
Access to continuous training and development programs.
Competitive compensation package (not specified in JD).
Collaborative work culture with supportive team dynamics.
Company Description:
A globally recognized clinical research organization specializing in comprehensive clinical trial management and regulatory affairs. The company partners with leading pharmaceutical and biotechnology firms to deliver safe, effective, and compliant healthcare solutions worldwide.
Work Mode:
On-site / Hybrid (Location not specified in JD)
Call to Action:
Ready to advance your clinical research career? Apply now for the Senior Clinical Research Associate role and contribute to cutting-edge clinical trial success.
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