Roles & Responsibilities:
• Coordinate and support remote site activities for assigned clinical studies.
• Serve as primary point of contact for site communications, document submissions, and activity coordination.
• Support pre-screening, screening, and recruitment activities as assigned.
• Manage subject re-consenting, acquire medical records, and conduct protocol activities as directed by the Principal Investigator.
• Perform data entry, monitor clinical databases, and respond to system queries.
• Maintain documentation in compliance with IRB/FDA policies.
• Assist with study closeout and other study-related activities as directed.
• Establish and maintain timely communication with sites and collaborate with other Central Study Coordinators.
Qualification:
• Bachelor’s degree or equivalent experience (minimum 2 years relevant combined experience).
Experience:
• Experience in clinical study coordination or study team support preferred.
• Familiarity with ICH/GCP guidelines and regulatory compliance.
Skills:
• Strong verbal and written communication skills.
• Ability to work independently and collaboratively in a remote setting.
• Proficient with web-based research platforms and Microsoft OS environments.
• Critical thinking, organization, multitasking, and initiative-taking abilities.
• Professional, articulate, and able to maintain confidentiality.
About the Organisation:
ProPharma Group is a global consulting firm that empowers biotech, medical device, and pharmaceutical companies to advance scientific breakthroughs and introduce new therapies. With expertise across regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma provides customizable, end-to-end solutions to de-risk and accelerate high-profile drug and device programs while fostering a diverse and inclusive workplace.
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