Job Description

The Research Fellow supports the planning and execution of clinical research studies through protocol development, operational management, and engagement with participating study sites.

Primary responsibilities and duties

• Develop study protocols and study-related documents.
• Coordinate ethics and regulatory submissions.
• Manage study start-up and day-to-day study operations.
• Monitor study timelines, milestones, and deliverables.
• Engage and support participating study sites throughout study conduct.
• Coordinate communication among investigators, study teams, and stakeholders.
• Ensure compliance with study protocols, GCP, and regulatory requirements.
• Monitor study progress and resolve operational issues.
• Maintain accurate study documentation and project records.
• Prepare study reports, presentations, and other research outputs as required.

Jobscope and Responsibilities

1. Study protocols and study documents completed within agreed timelines.
2. Ethics and regulatory submissions submitted on time.
3. Study start-up milestones achieved according to project timelines.
4. Study operations managed efficiently with minimal delays.
5. Regular engagement and timely communication with participating study sites.
6. Recruitment and study milestones tracked and monitored effectively.
7. Operational issues identified and resolved within agreed timelines.
8. Compliance with GCP, institutional, and regulatory requirements.
9. Accurate, complete, and audit-ready study documentation maintained.
10. Timely submission of study progress reports and project updates.
11. Positive feedback from Principal Investigators and participating study sites.

Qualifications

• PhD in Life Sciences, Biomedical Sciences, Public Health, Clinical Research, or other related health sciences discipline.
• Experience in clinical research, including protocol development and study coordination.
• Knowledge of clinical research regulations, ethics, and Good Clinical Practice (GCP) guidelines.
• Strong project management and organisational skills, with the ability to manage multiple studies and timelines.
• Excellent written and verbal communication skills.
• Strong stakeholder management and interpersonal skills to engage investigators and study sites.
• Ability to work independently and collaboratively in a multidisciplinary team.
• Strong analytical and problem-solving skills with attention to detail.