Senior clinical research Associate

Job Title: Senior Clinical Research Associate (CRA)
Location: Riyadh, KSA
Job Type: Full-time

Job Description

We are seeking a highly motivated Senior CRA to join our team on behalf of a leading multinational organization. The selected candidate will be responsible for overseeing and managing clinical trials from initiation to close-out, ensuring compliance with protocols, regulatory requirements, and SOPs.

Key Responsibilities:

• Oversee and coordinate clinical trial activities including investigator selection, patient recruitment analysis, and preparation of study-related documentation (protocols, CRFs, IBs, informed consents, agreements).
• Prepare and manage regulatory submissions and follow-up to ensure timely approvals.
• Organize and conduct investigator start-up meetings and site initiation visits.
• Ensure proper drug accountability at assigned clinical sites.
• Verify CRF data entries against source documentation.
• Ensure timely reporting and follow-up of all adverse events in accordance with protocol and applicable guidelines.
• Monitor trial activities in line with the protocol, monitoring plan, and SOPs.
• Plan, order, and manage clinical trial materials (CTMs) from sponsors.
• Maintain accurate and up-to-date Trial Master Files (TMFs) in compliance with local, legal, and ethical standards.
• Track completed CRFs and ensure timely transfer to data management.
• Maintain essential project files including EC approvals, CVs, IBs, protocols, consent forms, lab ranges, and correspondence.
• Deliver study-specific training to site staff and ensure effective ongoing communication.
• Escalate quality concerns to the Clinical Operations Manager (COM) and ensure corrective measures are implemented.
• Document site management activities, monitoring visit findings, and follow-up actions through detailed reports.
• Support patient recruitment strategies via investigator engagement, newsletters, and awareness initiatives.
• Collaborate closely with the COM and assume delegated responsibilities when required.
• Supervise and mentor CRAs and clinical trial assistants, providing guidance and training as needed.
• Report any instances of GCP non-compliance, misconduct, or fraud appropriately.
• Actively participate in departmental planning and contribute to continuous process improvement.

Qualifications:

• Education: Degree in Pharmacy or Medicine.
• Experience: Minimum of 2 years in clinical research.
• Residency: Based in Riyadh, KSA.

Job Type: Full-time