Job Description

Assumes responsibility for the conduct of assigned clinical trials and research studies. Coordinates research activities in compliance with study protocols and in a safe manner to ensure the wellbeing of study participants. Ensures the collection of robust clinical data for research purposes. Supports collaboration with multidisciplinary teams in hospitals across the Group.

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

QUALIFICATIONS & SKILLS:

• Bachelors degree in a Life Science or related subject (mandatory)
• Masters or other higher degree in a Life Science or related subject (preferred)

PROFESSIONAL EXPERIENCE:

• Minimum of three (3) years as a clinical study coordinator within a hospital setting or clinical trials facility
• Experienced with a wide range of clinical trials (phase 1-4), including participant recruitment, data collection and regulatory compliance
• Trained in ICH GCP guidelines
• Proficiency in Microsoft Office applications, including Teams
• Experience of clinical trial databases
• Strong understanding of clinical trial operations and wider regulations governing clinical trials
• Excellent organizational, communication and interpersonal skills