CRA II - Saudi Arabia

Join Our Global Team as a Clinical Research Associate (Level II) – Drive Innovation in Clinical Research

We are a leading organization with a proven track record of supporting the world’s top 50 pharmaceutical companies and over 750 biotech firms, having successfully managed more than 2,700 clinical trials across 100+ countries over the past five years. As a Clinical Research Associate (Level II) in our dynamic team, you will play a pivotal role in advancing medical innovation by overseeing and coordinating critical aspects of clinical monitoring and site management. This position offers a unique opportunity to contribute to groundbreaking research while ensuring compliance with global standards and regulatory requirements.

Key Responsibilities

In this role, you will be responsible for performing and coordinating all aspects of the clinical monitoring and site management process, including remote and on-site visits to assess protocol and regulatory compliance. Your duties will encompass managing documentation, ensuring adherence to sponsor-specific procedures, and maintaining compliance with ICH-GCP guidelines, applicable regulations, and standard operating procedures (SOPs). As a site processes specialist, you will safeguard the rights, well-being, and data reliability of trial participants while ensuring audit readiness. Your responsibilities will include:

• Risk-Based Monitoring: Conduct investigator site monitoring using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures. Implement corrective and preventive actions to bring sites into compliance and mitigate risks.
• Data Accuracy & Compliance: Ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) reviews during on-site and remote monitoring activities. Assess investigational product integrity through physical inventory and records review.
• Documentation & Reporting: Document observations in reports and letters in a timely manner, adhering to approved business writing standards. Escalate deficiencies and issues to clinical management promptly and follow through to resolution. Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Site Initiation & Close-Out: Participate in investigator meetings, identify potential investigators in collaboration with clients, and initiate clinical trial sites in accordance with regulatory and ICH-GCP obligations. Perform trial close-out activities, including the retrieval of trial materials and ensuring the completeness of essential documents.
• Regulatory & Audit Readiness: Respond to company, client, and regulatory requirements, audits, and inspections. Conduct on-site file reviews as per project specifications to ensure compliance with ICH-GCP and applicable regulations.
• Communication & Collaboration: Facilitate effective communication between investigative sites, clients, and the PPD project team through written, oral, and electronic channels. Provide trial status tracking and progress updates to the Clinical Team Manager (CTM) as required.
• Administrative & Process Improvement: Maintain and complete administrative tasks, such as expense reports and timesheets, in a timely manner. Contribute to process improvement initiatives and assist in the preparation of project publications and tools.

Qualifications & Experience

To excel in this role, you must possess a Bachelor’s degree in a life sciences-related field, a Registered Nursing certification, or equivalent education and experience. Proficiency in clinical research methodologies, ICH-GCP guidelines, and regulatory compliance is essential. Strong critical thinking, problem-solving, and communication skills are required to effectively manage site processes and collaborate with cross-functional teams. Prior experience in clinical monitoring, site management, or a related field is highly desirable.

Why Join Us?

As a Clinical Research Associate (Level II), you will be part of a global team dedicated to advancing medical research and improving patient outcomes. You will have the opportunity to work on diverse and impactful projects, develop your professional skills, and contribute to the success of cutting-edge clinical trials. We offer a collaborative work environment, competitive compensation, and opportunities for career growth in a dynamic and rewarding industry.