Introduction:
Join IQVIA, a global leader in healthcare intelligence and clinical research, and make a meaningful impact on the future of healthcare in Uganda! We are seeking a highly motivated Senior Clinical Research Associate (CRA) to oversee and manage clinical trial sites, ensuring compliance with protocols, regulatory requirements, and sponsor expectations. This is a full-time role based in Kampala, Uganda, offering the opportunity to work on cutting-edge research projects while advancing your career in a dynamic and supportive environment.
Key Responsibilities:
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Collaborate with sites to develop and track subject recruitment plans, ensuring alignment with project goals.
- Deliver protocol and study-related training to assigned sites, maintaining clear and consistent communication.
- Evaluate site practices to ensure adherence to study protocols and regulatory standards, escalating quality issues as needed.
- Track study progress, including regulatory submissions, patient recruitment, data collection, and query resolution.
- Maintain Trial Master File (TMF) and Investigator Site File (ISF) documentation in accordance with GCP/ICH and local regulations.
- Prepare and submit detailed monitoring visit reports, follow-up letters, and other required study documentation.
- Mentor and train junior clinical staff, including conducting co-monitoring visits.
- Support site financial management, including invoice retrieval and budget tracking, as applicable.
Requirements:
- Must-Have:
- Bachelor’s degree in a scientific discipline or healthcare-related field.
- Minimum of 4 years of on-site clinical monitoring experience.
- In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Strong understanding of clinical research protocols and therapeutic areas.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with electronic data capture systems.
- Excellent written and verbal communication skills in English.
- Strong organizational, problem-solving, and time-management skills.
- Nice-to-Have:
- Experience in financial management of clinical trial sites.
- Familiarity with recruitment strategies and patient enrollment optimization.
- Ability to build and maintain effective relationships with internal teams and external stakeholders.
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and inclusive work environment.
- Chance to work on impactful research projects that improve global health outcomes.
Call-to-Action (CTA):
If you’re passionate about clinical research and ready to take the next step in your career, we want to hear from you! Apply now by submitting your resume and a cover letter detailing your experience and qualifications to Click Here to Apply . Don’t miss this opportunity to join a global leader in healthcare innovation—apply today!