Research Associate American Hospital Dubai LLC

General:

• Coordinates daily study activities

• Supports Investigators with subject recruitment, scheduling and follow-up of participants

• Ensures compliance with the study protocol, International Council for Harmonisation Good Clinical Practice (ICH GCP) and regulatory requirements

• Maintains a flexible approach to meet the needs of the study and departmental research activities

Clinical Study/Trial Coordination:

• Acts as a central point of contact for external sponsors, CROs and other stakeholders to support the set-up of research studies and clinical trials

• Supports information gathering for feasibility assessments

• Liaises with all necessary departments to ensure the smooth set-up of research studies and clinical trials

• Drafts study documentation (including but not limited to the study protocol, consent forms, case report forms and other essential documents) using templates

• Organizes and attends study initiation meetings, monitoring visits and closure meetings throughout the study

• Develops study recruitment plan to ensure timely enrolment of participants in accordance with study timelines

• Develops study tools to support the scheduling of study visits and assessments 

• Reports adverse events in accordance with study protocols and Standard Operating Procedures

• Assists in the execution of clinical trial protocols, including the identification of eligibility criteria and setting up study procedures

• Collects, records, and maintains accurate participant data according to study protocols and regulatory requirements, ensuring data integrity and confidentiality

• Coordinates the collection, processing, and shipment of biological samples as required by the study protocol

• Maintains study Site Files and study-related inventories

• Liaises with the finance team and sponsors to raise invoices in a timely manner

• Supports Investigators with academic research projects with specific reference to: 

  • the design of studies

  • preparing study documentation

  • submission for regulatory approvals

  • designing and setting up study databases

  • collection of data and entry into study databases

  • drafting abstracts, manuscripts and other summary reports 

Compliance and Regulatory:

• Ensures adherence to clinical trial protocols and regulatory requirements, including GCP guidelines

• Maintains thorough and accurate documentation of all study-related activities, including participant interactions, data collection, and adverse event reporting

• Prepares for and supports internal and external audits by maintaining organized and compliant study records ensuring that the study is ‘audit-ready’ at any given time

• Monitors adherence to study protocols, ensuring compliance with regulatory standards and institutional policies

• Identifies areas for process improvement to enhance study quality and efficiency

Communication and Collaboration:

• Serves as the primary contact for study stakeholders, answering questions and addressing concerns throughout the trial period

• Collaborates with Principal Investigators, research staff, clinicians and the wider multidisciplinary team to ensure the successful execution and completion of clinical trials

• Assists discussions with external stakeholders (e.g., sponsors, CROs, other academic collaborators) to support broader research partnerships

Education and Support:

• Trains and mentors staff in clinical trial procedures and best practices

• Participates in educational sessions and seminars to stay current with developments in clinical research and nursing practices