Senior Clinical Research Associate📣 إعلان

About PDC CRO

Pharmaceutical Development Company (PDC) is a leading clinical research organization that provides full-service end-to-end solutions for Phase I to IV clinical trials and NIS/RWE studies across the Middle East and Africa region. PDC serves a diverse client base, including pharmaceutical, biotechnology, and medical device industries, as well as other CROs and academic organizations. The company is recognized as a leader in clinical research within the region, managing clinical projects from initiation to completion.

The Role: Senior Clinical Research Associate

PDC CRO is seeking a highly motivated and responsible Senior Clinical Research Associate to join its team in Riyadh. This full-time position requires 5-10 years of experience and involves overseeing clinical trial activities to ensure strict compliance with study protocols, international guidelines, and local regulatory requirements. The role is integral to the successful execution and quality control of clinical projects.

Key Responsibilities

• Participate in feasibility studies, including investigator outreach and information collection, adhering to confidentiality and SOPs.
• Conduct site selection and qualification evaluations under supervision.
• Assist during study set-up with submission, approval processes, and documentation preparation according to local requirements.
• Collect all Ethics Committee (EC) requirements for assigned studies.
• Coordinate and participate in study-specific trainings and meetings, including Investigator Meetings.
• Monitor and perform quality control of investigational sites, conducting monitoring visits in accordance with GCP and the study protocol.
• Review and report non-compliances, protocol deviations, and all Adverse Events/Serious Adverse Events (AE/SAEs) to the sponsor.
• Ensure accurate Source Data Verification (SDV) and proper transfer of Case Report Form (CRF) data to Data Management.
• Report trial progress to the Clinical Project Manager (CPM) through written reports, data collection, correspondence, and meeting participation.
• Ensure study conduct aligns with international and national regulatory requirements, the Protocol, and applicable Quality Documents (SOPs, WIs, Plans, Manuals).
• Organize and coordinate investigational product and study supply import/accountability, as well as biological sample export.
• Provide internal progress reports and complete relevant files in a timely manner.
• Ensure proper termination and close-out activities for all study sites and finalization of contracted tasks.
• Serve as the primary communication point for study-related issues raised by sites for studies led by the associate.
• Execute all activities in compliance with applicable SOPs, instructions, and principles.
• Act as a guide for CRA I and II personnel as needed.
• Adhere to ICH-GCP rules and other regulatory and ethical guidelines, including data protection regulations.
• Provide internal training to the team on specific topics.

Required Experience and Qualifications

Candidates for this role should possess 5 to 10 years of experience in clinical research. A strong understanding and consistent adherence to ICH-GCP, international and national regulatory requirements, and applicable quality documents (SOPs, WIs, Plans, Manuals) are essential for this position.

Work Environment and Benefits

Work is performed in both office and site/clinical environments, which may involve exposure to patients and standard electrical office equipment. Frequent domestic and international travel may be required based on study needs. PDC CRO offers job-specific training, opportunities for career development within a successful international company, a competitive remuneration package, and additional benefits related to work performance.

Application Information

PDC CRO is committed to developing its team and offers a professional environment for growth in the clinical research field. Qualified candidates are encouraged to apply.