Junior Clinical Research Associate Sponsor-dedicated

Position Overview

As a Junior Clinical Research Associate dedicated to sponsor projects, you will play a pivotal role in ensuring the successful execution of clinical studies by overseeing site monitoring and management activities. Your responsibilities will encompass conducting site visits, maintaining regulatory compliance, and fostering effective communication with study sites to uphold the highest standards of clinical research integrity. This role is ideal for a detail-oriented professional with a passion for advancing medical research and improving patient outcomes through meticulous oversight and collaboration.

Key Responsibilities

• Site Monitoring and Management: Conduct comprehensive site monitoring visits, including selection, initiation, routine monitoring, and close-out phases, in strict adherence to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and sponsor-specific requirements. Ensure sites comply with study protocols, regulatory standards, and ethical guidelines throughout the trial lifecycle.
• Subject Recruitment and Engagement: Collaborate with study sites to develop, implement, and track subject recruitment strategies tailored to project timelines and objectives. Monitor enrollment progress to enhance predictability and address recruitment challenges proactively, ensuring alignment with project milestones.
• Training and Communication: Provide protocol-specific training to assigned sites and establish clear, consistent communication channels to manage expectations, resolve issues, and maintain alignment with study goals. Serve as a liaison between sites and the broader study team to facilitate seamless project execution.
• Quality Assurance and Compliance: Evaluate the quality and integrity of site practices, including adherence to protocols, regulatory requirements, and data integrity standards. Identify and escalate quality concerns or deviations to appropriate stakeholders, ensuring timely resolution and mitigation of risks.
• Documentation and Reporting: Maintain meticulous records of site activities, including regulatory submissions, enrollment metrics, case report form (CRF) completion, and data query resolution. Ensure the Trial Master File (TMF) and Investigator’s Site File (ISF) are complete, accurate, and compliant with GCP and local regulatory mandates. Prepare and submit detailed visit reports, follow-up correspondence, and other required documentation to support study oversight.
• Cross-Functional Collaboration: Work closely with study team members, including project managers, clinical research coordinators, and data managers, to support project execution, troubleshoot challenges, and drive continuous improvement in study processes.
• Recruitment Planning and Financial Oversight (if applicable): Contribute to the development of site-specific subject recruitment plans and, where required, oversee financial management activities in accordance with clinical trial agreements. Retrieve and verify invoices in compliance with local regulatory and sponsor requirements.

Qualifications and Skills

To excel in this role, you must possess a blend of educational background, practical experience, and professional competencies. The ideal candidate will meet the following criteria:

• Education: A High School Diploma or equivalent is required, with preference given to candidates holding a degree in a scientific discipline or healthcare-related field. Equivalent combinations of education, training, and relevant experience will be considered.
• Experience: A minimum of a few months to one year of on-site monitoring experience is essential. Prior exposure to clinical research environments, including familiarity with GCP and ICH guidelines, is highly desirable.
• Technical Proficiency: Strong computer skills are required, including proficiency in Microsoft Word, Excel, and PowerPoint. Experience with laptop computers, iPhones, and iPads (where applicable) is beneficial for remote monitoring and data management tasks.
• Language and Communication: Fluency in both Arabic and English is mandatory, with excellent written and verbal communication skills to effectively engage with diverse stakeholders, including site personnel, sponsors, and regulatory authorities.
• Analytical and Organizational Abilities: Demonstrated proficiency in problem-solving, time management, and financial oversight. Ability to prioritize tasks, manage multiple projects, and adapt to evolving study requirements in a fast-paced environment.
• Interpersonal Skills: Capacity to build and maintain strong professional relationships with colleagues, site investigators, and external partners. A collaborative and client-focused approach is essential for fostering productive partnerships and achieving study objectives.

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence, dedicated to accelerating the development and commercialization of innovative medical treatments. By joining our team, you will contribute to transformative advancements in patient care and population health worldwide. For more information about IQVIA and our mission, visit https://jobs.iqvia.com.

IQVIA is committed to maintaining the highest standards of integrity in our hiring practices. We enforce a zero-tolerance policy for candidate fraud, and all submitted information must be truthful and complete. Any misrepresentations or omissions during the recruitment process may result in immediate disqualification or, if discovered later, termination of employment, in accordance with applicable laws. We value honesty, professionalism, and accountability in every aspect of our work.