Senior Clinical Research Associate
PDC CRO · Riyadh, Riyadh, Saudi Arabia
Apply & track with Apply EdgePharmaceutical Development Company is a leading clinical research organization, providing a Full-Service End-to-End Solution for Phase I to IV clinical trials and NIS /RWE studies in the Middle East and Africa region. Our clients include pharmaceutical, biotechnology, medical device industries, other CROs, and academic organizations. Our team is experienced in managing clinical projects from beginning to completion, PDC has been recognized among the leaders as Clinical Research Organization in the region.Due to our successful development, we are looking for highly motivated and responsible candidates for the position of:Name of position: Senior Clinical Research Associate- Location: Riyadh- Saudi ArabiaEssential Functions and Other Job Information Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.Site selection and qualification evaluation under supervision of senior personnelAssists during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements.Collects all ECs requirements per allocated studies.Coordination, assistance (if needed) and participation in any trainings and meetings (Inc. Investigator Meetings) related to the specific study.Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP.Review and reporting of all non-compliances/ protocol deviation, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.Reporting of trial progress to the CPM by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferencesEnsuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc)Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ ExportLicense (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.Providing any requested internal progress reports and completion of the relevant filesTimely coverage of all assigned trainingsEnsuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.First line of communication for any study related issues arisen by sites for studies lead by them.Execute any activities in compliance with applicable SOPs, instructions, and principles.Act as guide for CRA I, II in case of need.Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.Execute any activities in compliance with applicable SOPs, instructions, and principles.Provide internal training to the team on a specific topic.QualificationsEducation and Experience University degree with life science background or equivalent and relevant formal academic/ vocational qualification.Previous experience in the field of clinical research, managing at least 2 Interventional CT and covering all steps part of trial lifecycle (Qualification, successful study submission to IRB/RA, Initiation, Monitoring and Termination).Knowledge, Skills, and AbilitiesKnowledge of the relevant industrial guidelines, regulations, and business expectations respecting international and national legislation framework and practices.Effectively prioritizes and organizes work, managing independent tasks and consistently meetingdeadlines to support operational efficiency.Communicates clearly and professionally in both written and verbal forms, capable of understanding and applying process improvements.Resourceful problem solver who collaborates well within teams and contributes positively to achieving shared goals.Open to receiving and acting on feedback, committed to continuous learning and improvement.Adaptable and proactive in managing changing work conditions and priorities.Proficient in Microsoft Office and business software, supporting daily operational tasks.Fluent in English, with additional language skills viewed as advantageous.Maintains confidentiality and ethical conduct in daily work, handling sensitive information with professionalism and respect.Working Conditions and Environment• Work is performed in an office or site/clinical environment with exposure to patients and electricaloffice equipment.• Frequent travel/ drive both domestic and international as per need.The Company Offer:- Job-specific training- Work for successful international company, excellent career development opportunity in a perspective professional field- Very competitive remuneration package- Additional benefits related to work performance.Websitehttps://pdc-cro.comThe Assigned Country: Saudi ArabiaOnly short-listed candidates will be contacted for interviews.By submitting your application, you agree that your personal data will be processed by PDC in accordance with the applicable Data Protection Law and in strictly keeping your confidentiality.We are committed to fostering a diverse and inclusive workplace where every individual is valued and respected. Employment decisions are based solely on qualifications, performance, and business needs.