Senior Clinical Research Associate - Turkey (Freelance, 0.5 FTE)

About the role

A freelance Senior Clinical Research Associate is sought to support a clinical site in Turkey on a 0.5 FTE basis. The role covers clinical monitoring of assigned protocols and sites, ensuring studies are conducted and documented according to the protocol, SOPs, GCP and applicable regulatory requirements.

Key responsibilities

• Conduct all types of monitoring and co-monitoring visits, in person and remotely, including site initiation, interim and close-out visits, and write monitoring reports.
• Support study start-up activities such as site identification and feasibility, site documents, Ethics Committee submissions and site set-up.
• Develop monitoring documentation such as trackers, guidelines, plans, source document templates and site tools.
• Train site personnel on protocol requirements, source documentation and case report completion.
• Review source documents and case report forms for accuracy and completeness, and manage investigational supplies, including dispensing, inventory and reconciliation.
• Monitor site enrollment, terminations, monitoring visits, protocol deviations, serious adverse events and laboratory abnormalities, and review regulatory documentation.
• Communicate with sites, investigators, site staff, client personnel and cross-functional teams, and take part in project meetings and calls.

Required profile

• Bachelor's degree or equivalent combination of education and experience.
• More than 5 years of experience as a Clinical Research Associate.
• Knowledge of local laws, local regulatory requirements, ICH guidelines and GCP.
• Strong organization, attention to detail, prioritization and proactive planning; ability to solve problems and train others.

Required skills

• Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Electronic data capture (EDC), CTMS, IVRS and eTMF.
• Excellent verbal, written communication and presentation skills.