Clinical Research Analyst at Zenith Medical & Kidney Centre

Job Description:

• We are seeking a dedicated Clinical Research Analyst to join our dynamic team. In this role, you will play a pivotal part in facilitating the successful execution of clinical studies while adhering to industry guidelines and company procedures.
• Your meticulous attention to detail and proactive approach will contribute to the advancement of our research efforts.

Responsibilities:

• Provide comprehensive support throughout the lifecycle of assigned clinical studies, ensuring alignment with international and local regulator's guidelines, regional regulations, and company SOPs.
• Execute site evaluation, initiation, monitoring, and close-out visits in accordance with departmental protocols and study specifications.
• Develop essential study administration materials, including study-specific informed consent documents, trial manuals, plans, case report forms, and trial master files.
• Engage in productive interactions with investigational sites, key opinion leaders, and consultants as necessary.
• Manage correspondence and promptly address inquiries and concerns raised by investigational sites.
• Create study trackers, logs and reporting templates to streamline study oversight and updates.
• Deliver training sessions to site staff on study protocol, methodologies and electronic systems as applicable.
• Ensure adherence to Good Clinical Practices, investigator integrity and study procedures by conducting remote or on-site monitoring visits.
• Validate source documentation and prepare monitoring reports within designated timelines.
• Guarantee the accuracy and completeness of clinical data through electronic data reviews and on-site source documentation verification.
• Collaborate with medical monitors and drug safety personnel to review serious adverse events and identify potential safety trends.
• Generate and resolve study queries, working closely with sites to ensure accurate data reporting.
• Proactively identify and resolve issues and actively participate in process improvement initiatives.
• Efficiently manage tasks, collaborating with internal and external teams to establish project priorities and milestones.
• Organize and maintain project-level study documents within the electronic Trial Master File (eTMF), in compliance with SOPs.
• Contribute to training and onboarding efforts for clinical, regulatory affairs personnel, and cross-functional team members.
• Undertake additional responsibilities as assigned.

In addition, you will support the operational effectiveness of our Clinical and Regulatory Control Unit through the following:

• Sustain professional expertise by staying current with therapeutic areas, clinical research literature, and regulatory mandates.
• Perform secondary research and literature reviews to bolster internal reports.

If you are a detail-oriented professional with a passion for clinical research, we encourage you to join our team and make a significant impact on advancing medical knowledge and patient care.