Clinical Research Analyst at Zenith Medical & Kidney Centre

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
2 years ago

Additional Details

Job ID
56900
Job Views
98

Job Description



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.


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