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.
Responsibilities:
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:
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