Clinical Trials Assistant with Start Up and Finance Sponsor-dedicated

Position Overview

We are seeking a detail-oriented and organized Clinical Trials Assistant with specialized expertise in start-up and finance operations to support our clinical research initiatives. In this pivotal role, you will collaborate closely with Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) teams to ensure the seamless delivery of a complete and accurate Trial Master File (TMF). Your responsibilities will encompass a range of administrative and operational tasks designed to maintain compliance, streamline processes, and enhance the efficiency of clinical trial documentation and reporting.

Key Responsibilities

As a Clinical Trials Assistant, your core duties will include:

• Document Management and Maintenance: Assist CRAs and the RSU team in updating and maintaining clinical documents and systems, including the Trial Master File (TMF), to ensure site compliance and adherence to project timelines. Your meticulous attention to detail will be critical in tracking site performance and regulatory requirements.
• Clinical Documentation and Reporting: Support the clinical team by preparing, handling, distributing, filing, and archiving clinical documentation and reports in accordance with standard operating procedures and the project scope of work. You will also assist with periodic reviews of study files to ensure completeness and accuracy.
• Clinical Trial Supplies and Data Management: Facilitate the preparation, handling, and distribution of clinical trial supplies while maintaining accurate tracking information. Coordinate the management of Case Report Forms (CRFs), address queries, and ensure the smooth flow of clinical data.
• Communication and Coordination: Serve as a central point of contact for the clinical team, managing designated project communications, correspondence, and associated documentation. Your strong organizational skills will be essential in maintaining clear and efficient channels of communication.
• Site Visit Support: Accompany CRAs on site visits to assist with clinical monitoring duties, provided you have completed the necessary training. Your presence will help ensure that on-site activities align with regulatory and procedural requirements.
• Regulatory and Financial Support: Collaborate with the clinical team to prepare and submit documentation to Institutional Review Boards (IRBs) or Ethics Review Committees (ERCs). Additionally, support the preparation of submission packages for regulatory agencies and assist with the management of study insurance certificates, contracts, payments, budgeting, and invoicing.

Qualifications and Skills

To excel in this role, you must meet the following requirements:

• Education and Experience: A High School Diploma or equivalent is required. A minimum of one year of experience as a Clinical Trials Assistant with responsibilities in start-up and finance operations is essential. Experience in clinical research is strongly preferred.
• Regulatory Knowledge: A solid understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as well as applicable protocol requirements, is necessary. This knowledge will be further developed through company training.
• Technical Proficiency: Proficiency in Microsoft Word, Excel, and PowerPoint is required to manage documentation, track data, and prepare reports efficiently.
• Communication Skills: Strong written and verbal communication skills are essential, with fluency in both Arabic and English. Your ability to convey information clearly and professionally will be a key asset in this role.
• Organizational and Time Management: Exceptional time management and organizational skills are critical to balancing multiple tasks and meeting deadlines in a fast-paced clinical research environment.
• Collaboration and Relationship Building: The ability to establish and maintain effective working relationships with coworkers, managers, and clients is vital. Your interpersonal skills will contribute to a cohesive and productive team dynamic.

About IQVIA

IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Our mission is to create intelligent connections that accelerate the development and commercialization of innovative medical treatments, ultimately improving patient outcomes and population health worldwide. Join our team and contribute to groundbreaking advancements in healthcare by ensuring the integrity and efficiency of our clinical trial operations.

IQVIA is committed to maintaining the highest standards of integrity in our hiring process. We uphold a zero-tolerance policy for candidate fraud, and all information and credentials submitted in your application must be truthful and complete. Any misrepresentations or omissions during the recruitment process may result in immediate disqualification of your application or termination of employment, if discovered later, in accordance with applicable law.