· Support the Principal Investigator (PI) team in executing clinical trials, ensuring participant safety, protocol adherence, and data integrity.
· Act as a Principal Investigator for designated trials under senior PI guidance.
· Assist with competency checks and staff reviews, ensuring team members are current with required training and certifications.
Trial Feasibility and Strategy
· Participate in trial feasibility assessments and protocol reviews, collaborating with sponsors and internal teams to assess site capabilities and study requirements.
· Contribute to business development by identifying research opportunities and assisting in proposals and business cases.
· Support the team in reviewing trial costs and contracts.
· Ensure compliance with ICH-GCP, regulatory and ethical standards, and sponsor protocols.
· Support internal and external audits, inspections, and regulatory reviews.
· Stay up to date on the latest clinical trial developments and best practices.
· Provide clinical and operational support to Principal Investigators and research teams.
· Learn and develop as a mentor to guide junior staff and support trial delivery consistency.
Stakeholder Collaboration
· Communicate effectively with sponsors, regulatory authorities, and ethics committees to ensure alignment and trial success.
· Collaborate with internal teams, including the EMS Healthcare Medical Advisory Committee, to improve service delivery.
· Help ensure smooth clinical trial operations across community-based research sites, including recruitment and study coordination.
· Contribute to the development and refinement of EMS Healthcare’s operational protocols and quality systems.
· Attend Sponsor and client meetings as required.