Senior Clinical Research Associate

Position Overview

Our esteemed Pharmaceutical Development Company, a premier clinical research organization (CRO) specializing in end-to-end solutions for clinical trials spanning Phase I to IV, as well as Non-Interventional Studies (NIS) and Real-World Evidence (RWE) studies, is seeking a highly motivated and responsible Senior Clinical Research Associate to join our dynamic team in Riyadh, Saudi Arabia. With a robust portfolio of clients including pharmaceutical, biotechnology, and medical device industries, as well as other CROs and academic institutions, we are recognized as leaders in the Middle East and Africa region. This role offers a unique opportunity to contribute to groundbreaking clinical research while advancing your career in a fast-paced, collaborative environment.

Key Responsibilities

The Senior Clinical Research Associate will play a pivotal role in the execution of clinical trials, ensuring compliance with international and local regulatory standards, including ICH-GCP, while maintaining the highest ethical and quality standards. Your responsibilities will encompass a wide range of critical functions, including:

• Feasibility and Site Selection: Actively participate in feasibility studies, approaching investigators to gather essential information within strict timelines while adhering to confidentiality protocols and Standard Operating Procedures (SOPs). Assist in site selection and qualification evaluations under the guidance of senior personnel.
• Study Setup and Documentation: Support the study setup process by ensuring the preparation and submission of all required documentation in compliance with local regulatory requirements. Collect and verify all Ethics Committee (EC) requirements for assigned studies.
• Training and Coordination: Coordinate, assist, and participate in training sessions and meetings, including Investigator Meetings, to ensure all stakeholders are aligned with study protocols and regulatory expectations.
• Monitoring and Quality Control: Conduct monitoring visits at investigational sites in accordance with GCP guidelines, study protocols, and ICH-GCP standards. Perform source data verification (SDV) to ensure the accuracy and integrity of Case Report Form (CRF) data, and report all non-compliances, protocol deviations, and adverse events (AEs) or serious adverse events (SAEs) to the sponsor.
• Regulatory Compliance: Ensure the study is conducted in strict adherence to international and national regulatory requirements, study protocols, and applicable quality documents such as SOPs, Work Instructions (WI), and manuals.
• Investigational Product Management: Oversee the import, accountability, and export of investigational products and biological samples. This includes obtaining necessary import/export licenses, coordinating with courier services, and managing the distribution of study materials to sites or depots.
• Communication and Reporting: Serve as the primary point of contact for study-related issues raised by sites. Provide timely progress reports to Clinical Project Managers (CPM) by collecting trial-specific data, maintaining correspondence, and participating in project meetings and teleconferences.
• Study Closure and Training: Ensure proper termination of study sites and finalize all contracted tasks. Provide internal training to the team on specific topics as required and act as a mentor to junior CRAs when necessary.

Qualifications and Requirements

To excel in this role, candidates must meet the following qualifications and possess the necessary skills and experience:

• Education: A university degree in a life science field or equivalent, along with relevant formal academic or vocational qualifications.
• Experience: Minimum of two years of hands-on experience in clinical research, with a proven track record in managing at least two interventional clinical trials. This experience should cover all phases of the trial lifecycle, including qualification, study submission to Institutional Review Boards (IRBs) or Regulatory Authorities (RAs), initiation, monitoring, and termination.
• Knowledge and Skills: In-depth knowledge of relevant industrial guidelines, regulations, and business expectations, with a strong understanding of international and national legislation frameworks. Exceptional organizational and prioritization skills, with the ability to manage independent tasks and meet deadlines consistently.
• Compliance and Ethics: A thorough understanding of ICH-GCP, data protection regulations, and ethical guidelines. Commitment to adhering to all applicable SOPs, instructions, and principles.
• Communication and Leadership: Strong interpersonal and communication skills, with the ability to effectively liaise with investigators, sponsors, and internal teams. Demonstrated leadership potential to guide and mentor junior team members.

If you are a dedicated professional with a passion for clinical research and a commitment to excellence, we invite you to apply and become an integral part of our mission to advance healthcare through innovative clinical trials.